*This paper is submitted in satisfaction of both
the course requirement of the Food and Drug Law (Winter 2006) and
the LL.M. written work requirement.

*Abstract :

The recent stem cell scandal of fabrication of two
papers published in Science by Dr. Hwang Woo Suk shocked the
world and devastated the South Korean society. Investigations
conducted by the South Korean government have revealed a variety of
ethical and regulatory failures. In this paper, I first explain the
South Korean regulatory background to research conducted on human
subjects in general and on biotechnological research in particular,
and then analyze the ethical and regulatory problems affecting the
research for the two papers published in 2004 and 2005,
respectively. These problems can be summarized as: 1) problems
regarding egg donation (lack of informed consent and donation by
vulnerable subjects), 2) ambiguous record-keeping of research
funding, 3) insufficient reviews by the two local IRBs (an already
established IRB and a newly established IRB, both deferred to the
principal scientist's heavy-handed influence), 4) too close ties
between the research team and government officials, and 5) the
National Bioethics Committee's inertia and lack of
impartiality.

*This paper is based on the facts investigated and
disclosed by May 2006. Though the overall picture is likely to
remain the same, some of the details may require modification of
this paper in accordance to reflect results of further
investigations.

. Introduction

The recent stem cell scandal surrounding Dr. Hwang
Woo Suk’s research and publication shocked the scientific
world and devastated the South Korean society. After the outbreak
of the scandal, the National Bioethics Committee
(“NBC”),[1] Seoul National University,[2] the Board of Audit and Inspection,[3] and the Seoul Central District Prosecutors’
Office of the Republic of Korea,[4] respectively, began to investigate various aspects
of the scandal; and, its details have mostly been revealed. Though
the outright fabrication of scientific research and discoveries is
the most shocking part of this scandal, the ethical problems
underlying Dr. Hwang's actions also send a clear warning
signal.

Ethicists, religious groups and human right
activists have consistently raised ethical questions regarding the
progress of the research. The concerns were obvious from a
layperson’s point of view, even though it might have been
difficult for Dr. Hwang's “peers” to notice the
scientific fabrication of his highly specialized papers. However,
in South Korea, experts and government officials who were supposed
to supervise his research showed too much enthusiasm about his
alleged success and, in the process, forgot prudence and caution.
Instead, they shared the benefits, and even issued an official
indulgence for Hwang’s team, until it was revealed that most
of the research was fake. If the research itself were truthful, the
government and scientific peers, focusing only on the seemingly
fabulous outcome, would still have ignored ethical and procedural
injustice, and the research would have gone on for at least a while
without significant supervision, until a real tragedy broke out,
such as the death or severe injury of an egg donor.

South Korea does have a regulatory system to
oversee clinical trials and biotechnological research. However, no
safeguards that were in effect were unable to prevent Dr. Hwang's
ethical misconduct or his forgery of the data. The NBC, removed
from the daily workings of the local research labs, could not
properly oversee their behaviors. What they could do was impose
retrospective remedies such as the issuance of an investigative
report, suspension of the researchers’ qualifications, or
recommendation of stricter regulatory rules. The responsibility to
prevent ethical misconduct prospectively rested with the
researchers themselves and the local Institutional Review Boards
("IRBs"), but in this case, they dramatically failed.

Some people might mistakenly believe that this kind
of scandal cannot occur in developed countries that have
well-established regulatory systems known for their highest level
of bioethical concern. However, most of the ethical problems shown
in this scandal are neither new to nor unheard of in scientific
research.[5] Rather, when success is near at hand, there have
always been a few researchers who surrendered to the temptation to
bypass ethical considerations, hoping that nobody would uncover
their ethical misconduct, and even if they were caught later, they
would be forgiven if the outcome were successful. Therefore, a
regulatory scheme to protect and prohibit researchers from giving
in to such temptations is especially crucial in ethical matters, in
which, the traditional safeguards that guarantee the truthfulness
of the research, i.e., peer review, the referee system and the
process of replication,[6] might break down. This scandal provides an
opportunity to review current regulations in the biomedical and
biotechnological fields and to seek remedies in the hope of
preventing such ethical crises.

The purpose of this paper is twofold. One is to
elicit what caused the ethical failures of this scandal to readers
who do not speak Korean. Though the overall story has been
disclosed in English, many small details, which are important to
understand how those minor wrongdoings culminated in this huge
scandal, have not yet been fully interpreted. The other purpose is
to prevent similar scandals from occurring again. To prevent
another ethical failure, of any proportion, we need to articulate
the problems and establish a safer regulatory regime. The South
Korean authorities, though had once failed in many aspects to
supervise Dr. Hwang's research, did not hesitate to reveal even
their own problems and sins, realizing that if they tried to cover
up or turn their eyes from the misconduct again, the trust of the
public toward scientific research would never recover, and the
price would be huge. This paper owes much to their swift and
through investigations.

In this paper, I first summarize the regulatory
background and structure related to the scandal surrounding Dr.
Hwang’s stem cell research fabrication, and then focus on the
ethical problems revealed thus far. In conclusion, I recommend
several reform proposals to strengthen research ethics.

. How Regulations Were Established, Worked
and Failed

1. A brief
overview of stem cell research regulations in South Korea

Stem cell research in South Korea has been
regulated in two different areas. One is the general regulation of
clinical trials and protection of human subjects, which has
gradually developed from the late 1980s. The other is the more
specific regulation of biotechnology, which has been intensely
discussed since the late 1990s. These two areas of regulation
partly overlap, but their main focuses and objectives differ.

a. General
regulations of research on human subjects

Regulating research on human subjects in South
Korea increased substantially from the early 1990s, mainly in
response to burgeoning clinical trials for new drugs. In 1986 the
South Korean government, as a settlement for bilateral trade
disputes with the United States, agreed to offer higher patent
protection for medicines and chemical compounds.[7] Within a year, the National Assembly of South Korea
amended the Korean Patent Act to accord with the above agreement.
The amended Patent Act broadened patent rights for chemical
compounds and drugs, and admitted alien non-residents’
standing to sue in patent infringement lawsuits.[8] Until then, most Korean pharmaceutical companies had
concentrated on manufacturing and selling generic drugs for which
the patent had already expired, or copying drugs that were
chemically identical to the patented drugs but produced by
different methods to avoid lawsuits for infringement of method
patents.[9] However, intellectual property protection for drugs
has been enhanced by the amended Patent Act and later by the
Agreement on Trade Related Aspects of Intellectual Property Rights
(TRIPs),[10] making it more difficult for South Korean
pharmaceutical companies to earn revenue from their former
practices. Realizing the changing environment of the industry, they
began to develop new drugs from the early 1990s forward, and their
efforts came to fruition in the late 1990s.[11]

The South Korean government acknowledged the
necessity to regulate clinical trials and offer protection to human
subjects. The Ministry of Health and Welfare (MHW) of South Korea
issued the Guidelines for Korean Good Clinical Practice
(KGCP)[12] on December 28, 1987 as non-binding guidelines
applying to pharmaceutical companies and research institutes who
conducted clinical trials for new drugs; amended them on January 5,
1995 as binding regulations;[13] and last amended them on
January 4, 2000[14] to adopt the Guidelines for Good Clinical Practice
(“ICH-GCP”) E6 version issued by the International
Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use.[15] With this last amendment, the KGCP became almost
identical to the ICH-GCP and could meet the international
standards, especially pertaining to IRBs.

In addition to the administrative regulations on
clinical trials, civil case laws and ethical self-regulation by the
medical community have also improved. After the end of an almost
forty-year-long dictatorship in 1987, justice and ethics have again
been emphasized. The medical profession was no exception. Medical
malpractice lawsuits have increased rapidly, and the notion of
“informed consent” has been adopted in contracts and
torts through the interpretation of the Civil Code of South Korea.
Since the late 1980s, the Supreme Court of South Korea began to
apply this principle vigorously.[16] Informed consent is now an established doctrine,
and even if the plaintiff cannot prove the causality between the
lack of informed consent and the actual harm, if she proves the
lack of informed consent itself in the medical treatment in
question, she may be awarded at least compensatory damages for the
emotional distress caused by the deprivation of self-determination
or loss of the right to choose.[17] The Korean Medical Association (KMA) declared the
Guidelines of Ethics for the Medical Profession as self-regulatory
rules.[18] They reiterated doctors’ general ethical
duty[19] and the doctrine of informed consent,[20] prohibited trading in human eggs for in vitro
fertilization,[21] limited research on human cloning to the cure and
prevention of specific diseases,[22] and recommended the establishment of a local
ethics committee in each hospital and research
institution.[23] As the KMA held the power to sanction member
doctors who violated the mandatory clauses of the guidelines, the
guidelines gained some degree of binding force. Thus, at least
facially, the regulatory structure for clinical trials and
protection of human subjects was established.

b. Special
Regulations on Biotechnology and Stem Cell Research

The first law on biotechnology enacted in South
Korea is the Genetic Technology Support Act[24] (later renamed the Biotechnology Support
Act,[25] hereinafter “Biotechnology Support
Act”). However, its focus was not on restricting but on
promoting the biotech industry and its research efforts.[26] Art. 15 of the Act mandated that the government
announce guidelines on biotechnological research to prevent
biohazards and ethical
problems,[27] but the "Guidelines on Recombinant DNA
Experiments" according to Art. 15 of the Act had not been issued
until South Korea joined the Convention on Biological Diversity in
1997. When the Guidelines were issued in accordance with the
Convention, it contained only one very ambiguous article on ethics
in biotechnological research.[28] Human embryonic stem cell research found itself in
a regulatory vacuum for a while, as the KGCP applied only to the
clinical trials on human subjects, and the Guidelines on
Recombinant DNA Experiments offered no further guidelines on that
matter.

It was the birth of “Dolly the Sheep”
that evoked a public outcry for further regulation of stem-cell
research. On February 22, 1997, a research team led by Dr. Ian
Wilmut and Dr. K.H.S. Campbell of Roslin Institute in Scotland
announced that they succeeded in cloning a sheep by somatic cell
nuclear transfer (SCNT), [29] in which “a cell is placed in a de-nucleated
ovum, the two cells fuse and then develop into an
embryo.”[30] This was the first successful mammalian cloning,
and everyone realized that human cloning might succeed in the near
future. One episode of an alleged human cloning by Dr. Lee Boyeon
and his coresearchers at the fertility clinic of Kyunghee
University in South Korea,[31] other researchers' cloning successes on other
mammals[32] and rising concerns regarding various ethical
issues also necessitated a new comprehensive bioethics law.[33] Three different amendments to the Biotechnology
Support Act were proposed by congressmen from 1997 to
1999,[34] and two different drafts of an independent act on
bioethics were proposed by the Ministry of Health and Welfare
(2000) and then, by the Ministry of Science and Technology
(2002).[35] Later the debates evolved mainly around the
governmental drafts. Biotechnological researchers and the biotech
industry supported the Ministry of Science and Technology version,
while bioethicists and NGOs strongly supported the Ministry of
Health and Welfare version.[36] It seemed impossible to reach a uniform bill.
While the legislative process stalemated under endless debates,
guidelines issued by several associations were the only,
insufficient, safeguards against unethical human embryonic stem
cell research.[37]

However, when the South Korean branch of
CLONAID™[38] announced that they had already cloned human
embryos and implanted them in three Korean surrogate mothers’
uteruses[39] and later declared that a cloned baby named "Eve"
had been born, both ministries and legislators recognized the dire
need to prohibit human cloning, and agreed on a single
draft,[40] mostly following the Ministry of Health and
Welfare version, but leaving some possibilities for therapeutic
cloning.[41] The Bioethics and Safety Act passed the National
Assembly on December 29, 2003, was promulgated on January 29, 2004,
and took effect on January 1, 2005.[42] Important provisions of the Act include: 1)
establishment of the National Bioethics Committee to deliberate on
matters concerning the establishment of major policies respecting
bioethics and safety in biotechnology, under the
President;[43] 2) general prohibition of human cloning;[44] 3) prohibition of human sperm or egg
trading;[45] 4) permission of stem cell research using residual
embryos[46] and by transplanting the nucleus of a somatic cell
into a human egg[47] for treatment of rare or incurable diseases under
the review of the National Bioethics Committee and the approval of
the Minister of Health and Welfare;[48] 5) regulation of gene therapy and the DNA bank,
and 6) criminal punishment for the violations of the Act.[49]

The National Bioethics Committee was formed on
April 7, 2005, more than three months after the Bioethics and
Safety Act and its Presidential Decree took effect on January 1,
2005. Following the Act[50] and the Decree[51] the NBC was formed, composed of seven Ministers
form related government departments; seven persons with much
professional knowledge and research experience in the life sciences
or medicine who represented academic, research or industrial
circles, or scientists; and seven persons who represented
religious, philosophical, ethical, social science or legal circles,
non-governmental organizations or women.[52] This was the regulatory structure in place when
Dr. Hwang and his team conducted stem cell research.

Dr. Hwang’s human embryonic stem cell
research began in 2002. It was a transitional period when
biomedical and scientific policies changed from a laissez faire
approach to promulgation of stricter regulations, but
people’s attitudes had not progressed as rapidly. This
discrepancy caused many problems in executing the laws and
regulations.

a. Background

Dr. Hwang Woo Suk, a former professor of the
College of Veterinary Medicine at Seoul National
University,[53] had already achieved renown as a veterinary
scientist in South Korea, but in 1999 when he announced that his
team succeeded in cloning cows, he acquired national fame.[54] It was the fifth success of mammalian cloning by
the SCNT in the world, and was praised by the South Korean public
as welcome news, boosting national morale that had been quite low
since the economic crisis of late 1990s. As he did not submit any
paper and did not keep scientific records of his research,[55] the results could not be scientifically
reviewed.[56] Still, government officials and politicians were
eager to support further research and share the accolades with him.
From September 1, 1999 to August 31, 2000[57] he was given funding totaling approximately $1.6
million from the Ministry of Science and Technology for a project
seeking to mass-produce high-capacity dairy cows by SCNT. Nobody
questioned whether it would be proper to offer government funding
for research that had not been properly peer reviewed. Though the
project failed completely, Dr. Hwang's reputation remained intact.
[58]

Unlike many other scientists who confined
themselves to the research lab, Dr. Hwang was proved to be talented
at public relations. He often invited reporters to his lab and
showed them his experiments. He hired professional photographers
for his press releases. He announced his research plans regularly,
such as his attempt to clone the nearly extinct Siberian tiger, the
national symbol of Korea, from a tiger cell donated by the North
Korean government,[59] or to produce gnotobiotic (sterilized) miniature
pigs, or to make genetically engineered cows that are resistant to
mad cow disease.[60] These well-timed announcements kept Dr. Hwang in
the public's eye and led to huge amounts of governmental funding
and private donations. Dr. Hwang was also proved to be an active
public lecturer. He conveyed his message with finesse, suggesting
that the future of the nation depended on the development of
biotechnology, and more governmental grants and public support
should be forthcoming. His often cited comments, such as "though
science has no border, a scientist does have a nationality,"
emphasized his patriotism, while hits remark, "my calendar has only
mon-tue-wed-thu-fri-fri-fri -- there is no Saturday or Sunday"
underscored his tireless efforts. He also frequently met with
patients suffering from incurable diseases and gave them hope,
saying that in ten years treatments to help them would be developed
through the stem cell research.[61] He acquired national fame through such activities
and maintained close ties with the Minister of Information and
Communication, the Secretary to the President for Policy
Coordination, and the Advisor to the President for Information,
Science and Technology. He even met President Roh Mu Hyun in person
and secured a promise of support. With such renown and
relationships, Dr. Hwang could freely proceed to conduct his
research under the auspices of the government.

b. Ethical and
Regulatory problems relating to the 2004 paper

On February 12, 2004, Dr. Hwang Woo Suk and his
research team announced that they had succeeded in the
“derivation of a pluripotent embryonic stem cell line from a
cloned human blastocyst.”[62] This meant that they had succeeded in creating a
human embryo through cloning, and had extracted embryonic stem
cells from it, for the first time in the world. They allegedly used
242 unfertilized human eggs extracted from 16 donors, "removed the
genetic material from the eggs and replaced it with genetic
material obtained from cumulus cells, the adult cells that cling to
eggs."[63] Among them grew 30 blastocysts, of which 20
inner cell masses were removed, and one stem cell line was grown
among the masses, according to their announcement and their
paper.[64]

Their work stunned the world and was widely
accepted as truthful.[65] Some scientists envied the research environment of
South Korea where less regulations existed and such a large scale
of egg donation was available.[66] Many bioethicists expressed their concern that
this success would open the door to the "slippery slope" of human
cloning and human enhancement.[67] Dr. Leon Kass, an ethicist famous for his anti
human-cloning stance,[68] worried about the looming possibility of actual
human cloning in an e-mail interview with the New York Times
.[69]

As well as the general opposition on the human
embryonic stem cell research, more specific ethical criticism was
raised by Korean bioethicists[70] and Nature magazine[71] . They may be summarized as:

1) Suspicions about egg donation, 2) ambiguous
records on research funding, 3) insufficient review by the IRB, and
4) too close ties between the research team and the government
officials who had the responsibility to oversee the research.

1) Suspicions about egg donation

Dr. Hwang and his team stated in the supporting
online material of the 2004 paper, "1) donors were voluntarily
donating oocytes and cumulus cell (including DNA) for therapeutic
cloning research ... with no financial payment ... 5) neither
donors nor their family, relatives, or associates may benefit from
this research."[72] However, when he claimed that his team used 242
eggs donated from 16 donors and not a single egg had been
purchased, many people argued that it was unrealistic for so many
women to had undergone the painful egg procurement procedure
without compensation, and raised the possibility that those eggs
might have been purchased, violating the then existing guidelines
against egg trading.[73] Another claim was egg donations by vulnerable
subjects. David Cyranoski of Nature magazine claimed that a
female researcher in Dr. Hwang's team stated in an interview with
Nature magazine that she, along with another female
researcher, had donated eggs themselves.[74]

These were serious assertions and accusations.
First, though the Bioethics and Safety Act had not yet been
effectuated, which prohibits ova-trading by criminal punishment,
many people thought that researchers should restrain themselves
from purchasing ova, especially for ethically contentious stem cell
research,[75] until the Act took effect on January 1, 2005. In
addition, there were other guidelines applicable to Dr. Hwang's
research that clearly prohibited researchers from purchasing eggs
or sperm. The KMA's Guidelines on Research of Cloning Lives
issued in May 1999 strictly prohibited trading of sperm, eggs or
somatic cells.[76] As the KMA's guidelines applied at the very least
to the co-researchers on Hwang’s team who had medical
licenses,[77] they were bound to abide by the guidelines, and
paying for the eggs would have been a violation thereof. Also
the Stem Cell Research Center Ethics Committee Guidelines for
Review of Research Proposals applied to a research that
received grants from the Stem Cell Research Center of South Korea,
which prohibited egg-trading.[78] As we see 2) infra, it was quite possible that Dr.
Hwang’s team had been awarded such grants.

Second, the KGCP stipulated that special attention
should be paid to trials that may include vulnerable subjects
(individuals whose willingness to volunteer in a clinical trial may
be unduly influenced by the expectation, whether justified or not,
of benefits associated with participation, or of a retaliatory
response from senior members of a hierarchy in case of refusal to
participate, such medical, pharmacy, dental, and nursing students,
subordinate hospital and laboratory personnel).[79] It drew its origins from the Declaration of
Helsinki, Art. 8,[80] one of the fundamental ethical rules set for the
protection of human subjects. Therefore, the accusation of donation
from vulnerable subjects invoked stronger reactions from the
international scientific society than egg trading. While egg
trading has been permitted as an economic activity or a due
compensation in some countries including the United States, abuse
of vulnerable subjects is too reminiscent of notorious incidents in
the history of human experiments.

Dr. Hwang responded that his experiments complied
with all existing international and South Korean ethical rules,
rebutting, "Nature 's claim is totally groundless. I swear
none of my students donated eggs for the research. For some reason,
the journal is trying to undermine our study.''[81] He and Dr. Moon also criticized the Korean
Bioethics Association as "in our opinion, not neutral and advocates
restricting the pace of biomedical advancements, viewing new
techniques as threats to society."[82] Nevertheless, Dr. Hwang did not presented any
further evidence to back up his assertions, on the ground that the
identities of egg donors should be kept confidential to protect
them.

Considering all these disputes, the South Korean
government and the IRB of Hanyang University Hospital that reviewed
Hwang's research should have initiated an investigation on the
ethics and legality of the egg donations at that time. But they did
nothing. Left alone to launch an investigation, Park Kiyoung, the
Advisor to the President for Information, Science and Technology
advocated the research herself, asserting "all the ethical issues
had already been settled when Dr. Hwang published the paper in
Science , and he went through all the regulatory procedures
and the IRB review."[83] From then forward, the egg donation issue had
never received government attention until the onset of the
scandal.

The recent investigation by the NBC[84] and the Seoul Central District Prosecutors'
Office[85] has revealed so many problems including egg
trading and egg donation from vulnerable subjects. According to the
NBC's intermediary report and the Seoul Central District
Prosecutors' Office's final report, the following facts were
revealed:

From November 24, 2002 to December 24, 2005 more than 2,200
eggs from 138 women were donated to Dr. Hwang's lab through four
hospitals,[86] and among them more than 97 women were monetarily
compensated[87] and some of them were introduced through an
"egg-broker."[88]

More than 1,500 eggs procured from 92 women at the MizMedi
Hospital completely lacked an IRB review, and egg donation
conducted at the Hanna Women's Clinic lacked review of compensation
paid.[90]

Most of the egg donors were offered insufficient information
regarding possible side effects, and prospective and retrospective
protection of patients from side effects were also
insufficient.[91]

Informed consent forms used for egg donations in four hospitals
lacked proper explanation of the purpose of the research and
potential side effects.[92]

In the early stages of the research (May 2002 to June 2003)
ovaria extracted by hysterectomy from 29 patients at Hanyang
University Hospital lacked patients' informed consent
completely.[93]

The stem cell scandal frustrated and enraged
volunteer donors who have endured the pain and ensuing side effects
with the pride that they were contributing to finding a cure for
serious diseases. Those egg donors, with the help of women's rights
activists, filed tort lawsuits against the MizMedi Hospital where
the ova had been procured, Hanyang University Hospital to which the
reviewing IRB belongs, and the South Korean government who had the
responsibility to supervise ova donations.[94] All of these problems could have been prevented,
if the regulatory system in place had functioned properly.

2) Ambiguous Records on Research Funding

Many grants offered for stem cell research have
restrictions based on the nature of the funds. The source of
funding decides what rules and regulations to apply. For example,
on August 9, 2001 the Bush Administration decided that federal
funds would not be used for the cloning of human embryos for any
purpose[95] except for research using the already existing 16
stem cell lines derived under certain specified conditions. This
decision, however, does not prohibit stem cell research by a
private company using private funds.[96] Therefore, it is crucial to clarify what money
has been used for what research. The situation is no different in
South Korea.

The 2004 paper elicited in its footnote 30 that
their study "was supported by grants from Advanced Backbone IT
Technology Development (grant IMT2000-C1-1) to [Woo Suk Hwang] and
the Stem Cell Research Center[97] (grant M102KL0100-02K1201-00223) to [Shin Yong
Moon]."[98] If so, the research should have followed the
Stem Cell Research Center Ethics Committee Guidelines for Review
of Research Proposals[99] issued by the Stem Cell Research Center in May
2003. As well as the statements in the 2004 paper's footnote 30
corroborating that the grants from the Stem Cell Research Center
had been spent for this research, a government official's proud
statement found in the announcement to the 2004 paper, "this world
class paper by Dr. Hwang and Dr. Moon is related to the Stem Cell
Research Center... the Stem Cell
Research Center granted Dr. Moon approximately 1.9 million dollars,
and 500,000 dollars of which has been used for this stem cell
research."[100]

The Stem Cell Research Center Ethics Committee
Guidelines for Review of Research Proposals[101] apply to research awarded the Center's
grants.[102] The then current Guidelines (later amended
February 2006) stipulated that it was prohibited to produce human
embryos for the purpose of stem cell research;[103] embryos donated to the research should be
derived from frozen surplus embryos produced for infertility
treatment through in vitro fertilization that have been kept for
more than five years and are soon to be discarded;[104] and the research involved should be carried out
in compliance with the provisions set forth in these guidelines for
stem cell research.[105] Therefore, no research by SCNT methods should
have been conducted using grants offered by the Stem Cell Research
Center.[106] Recognizing the problem, Dr. Hwang and Dr. Moon
later denied the use of government grants for their research. They
explained that the grant from the Stem Cell Research Center was a
mere "technical grant,”[107] and in response to the Korean Bioethics
Association as to what the term technical grant meant.[108] have never given a proper answer. This issue has
not been investigated by the Stem Cell Research Center or by its
Ethics Committee, and the only IRB involved, the IRB of Hanyang
University Hospital, did not ask that the source of research
funding should be cited in the research protocol.[109] If funding had been properly disclosed, the
applicable governing rules might have been determined in the early
stage and more oversight might have been conducted.

Dr. Hwang never kept thorough financial records of
his research budgets, and even laundered money. This seriously
impeded the accountability and transparency surrounding his
research monies. In 2006, the Board of Audit and Inspection of
Korea investigated governmental funds and private
donations[110] awarded Dr. Hwang from 2001 to 2005,[111] and the Seoul Central District Prosecutors'
Office also conducted a more thorough investigation of Dr. Hwang
and his research team's embezzlement and fraud.[112] Both institutions found him to have
inappropriately managed his research grants. He mixed public and
private grants and his personal income in private bank accounts
under his or third parties' names (all 63 names in total; most of
these third parties were subordinate researchers in his lab,
graduate students under his direction, and or his relatives) and
laundered money for himself by extracting a considerable amount of
cash from one account and depositing it to different accounts
repeatedly,[113] which made investigation almost impossible.
Despite a thorough investigation by the Board of Inspectors, $2.8
million remains unexplained among $16.4 million in governmental
grants and $6.2 million in private donations given to Dr.
Hwang.[114] According to the investigations conducted by
relating authorities, Dr. Gerald P. Schatten of the University of
Pittsburgh, the corresponding coauthor of the second paper, was
given "honoraria totaling $40,000 within a 15-month period from Dr.
Hwang – including $10,000 paid in cash while attending a
press conference following publication of the 2005 paper –
amounts that seems to us as far above normal honoraria for
consultation";[115] furthermore, Dr. Hwang deposited $700,000 in his
private savings account; [116] bought his wife a car worth $27,000;[117] donated $55,000 to politicians;[118] handed $25,000 to $30,000 to the egg broker to
purchase eggs; [119] gave $30,000 to Kim Sunjong, Dr. Hwang's junior
researcher and main actor in data fabrication at the wake of the
stem cell scandal, probably to ensure his secrecy;[120] and distributed the $500,000 of the money left
in his checking accounts to his co-researchers arbitrarily when the
fabrication was revealed.[121] It is still unclear how much of the sums spent
was obtained from the research grants, because there is no way to
distinguish public grants, private donations and his personal
income combined in the 63 private bank accounts.

3) Insufficient Review by the IRBs

The Bioethics and Safety Act that mandates an IRB
review did not directly apply to the 2004 paper.[122] Many people suspected that this clause of
one-year delay was inserted by Park Kiyoung, the Advisor to the
President, solely to give Dr. Hwang enough time to finish the
ongoing human embryonic stem cell research for the 2004 paper.
Still, there were other regulations and guidelines to follow, which
did not exempt Dr. Hwang's research from the IRB review.

A. IRB Review on egg donation

As extracting unfertilized eggs from women is a
non-therapeutic clinical trial on human subjects, the KGCP applied
to the egg donation as a binding regulation. Therefore, the local
IRB of an institution in which the egg procurements were conducted
should have followed the requirements mandated by the KGCP, not
least of all the duty to safeguard the rights, safety, and
well-being of all trial subjects (especially vulnerable subjects);
to obtain and review important documents such as written informed
consent form(s) and consent form updates that the investigator
proposes for use in the trial, subject recruitment procedures (e.g.
advertisements), written information to be provided to
subjects;[123] and to conduct continuing reviews for at least
once a year.[124]

It was the IRB of Hanyang University Hospital that
reviewed the ethics of egg donations for the 2004 paper.[125] The IRB had already been established and in
place when the principal investigator, Dr. Hwang Yunyoung,[126] asked for a review of the research protocol on
"establishment and derivation of stem cells through somatic nuclear
cell transplant" (the research for the 2004 paper) in November
2002. The board, composed of 15 members, three of whom were not
doctors (a reverend, a nurse, and a pharmacist) and one who was
independent of the institution (a professor at another medical
school), seemed to fulfill the structural requirements of both KGCP
Art. 8 §1 and ICH-GCP 3.2.1. The board also had its own
internal IRB Guidelines and the Standard Operating Procedure (SOP),
fulfilling KGCP Art. 8 §4.[127]

However, there was no obstetrician/gynecologist
among the IRB members, although the principal investigator was a
respected obstetrician/gynecologist and former Dean of the
institution's own medical school.[128] Under this arrangement, a thorough and
impartial review by the local IRB was structurally impossible,
because an IRB should have both scientific experts and impartial
ethicists as its members if it wishes to conduct a balanced review.
Furthermore, most of the IRB members were busy doctors or
professors who had little time to spare for the extra work. The IRB
sessions were held only once in a month and reviewed more than ten
protocols within an hour and a half. Subcommittees composed of
three board members conducted prior reviews, but it was not
sufficient and the main sessions turned formalistic.[129]

At the first review session on November 5, 2002,
the IRB, issuing a conditional approval on the research protocol,
ordered the principal investigator to submit monthly intermediary
reports on the use of donated oocytes and informed consent forms
received from the patients.[130] It was a proper order considering the
controversial nature of the research and potential adverse side
effects that might be experienced by the egg donors. These reports,
if submitted, would also have provided bases for continuing review
for the propriety of egg donation and might have prevented the
researchers' misconduct presented in supra 2). However, the
order was never complied with by the investigators nor enforced by
the IRB.[131] Instead, on February 10, 2003, the IRB issued an
unconditional approval of the protocol, even though the
investigators had never submitted a monthly follow-up report so
far. The IRB never admonished the investigators for their
noncompliance at its subsequent review sessions on protocol
amendments held on April 29, 2003 and December 24, 2003,
respectively. The IRB could nor detect that ovaria of 29 patients
extracted by hysterectomy had been used for the research without
any informed consent.[132]

The IRB's hands-off attitude similarly appeared
when it reviewed the contents of the first and second protocol
amendments.[133] The original protocol stated that only the ova
or ovaria extracted by the result of a hysterectomy would be
donated, but the amendments extended the range of ova donors to
healthy non-patients. If such an important contents of the protocol
had been amended, the informed consent forms, the subject
recruitment process (e.g. advertisements), and the written
information to be provided to subjects should also have been
amended and updated. But the IRB issued its approval of the
amendments unconditionally, without asking for the requisite
amendments.[134]

When the research was completed, a summary of the
final paper was submitted to the IRB. Later investigation revealed
that all the eggs used for the 2004 paper had been extracted at
clinics other than those at Hanyang University Hospital,[135] and not one of the egg procurements were
reviewed by the IRB. If the IRB had asked for a full version of the
paper, in which Hanyang University Hospital was designated as the
only oocyte extraction site,[136] it might have had another chance to correct the
researchers' misconduct.

Other problems underlying the IRB review further
contributed to the ensuing ethical failure. Though the research
protocol lacked information on research funding, the IRB did not
request such information.[137] Though the investigator should not participate
in the deliberations of the IRB or in the vote/opinion of the IRB
except for providing information on an aspect of the
trial,[138] investigators were casual about attending the
meetings and influencing decisions.[139]

Most of the issues that needed to be redressed, had
already been raised by bioethicists, civil rights activists,
Nature magazine and several other media outlets shortly
after the publication of the 2004 paper. The IRB, however, did not
conduct a follow-up review and even refused the demand of the
National Human Rights Commission of South Korea to present its
records of review sessions relating to the 2004 paper.[140]

These problems are not unique to the South Korean
research environment. In 1998, a report issued by the Office of the
Inspector General of the United States, Institutional Review
Boards: A Time for Reform ,[141] pointed out six major problems in IRBs: 1) they
face major changes in the research environment; 2) they review too
much, too quickly, with too little expertise; 3) they conduct
minimal continuing review of approved research; 4) they face
conflicts that threaten their independence; 5) they provide little
training for investigators and board members; and 6) neither IRBs
nor HHS devote much attention to evaluating IRB
effectiveness.[142] These concerns encompass all failures that took
place in the IRB of Hanyang University Hospital.
B. IRB Review on the Ethics of Human Embryonic Stem Cell
Research

No IRB, government agency or committee reviewed the
ethical aspects of the stem cell research by SCNT for the 2004
paper, even though guidelines applicable to the research and
ethical principles mandated that they should.[143]

The researchers’ stance was that as they had
spent only private money, there were no binding guidelines to their
research, and therefore no IRB review would be required.
Nevertheless, the Bioethics and Safety Act mandating an IRB review
on human embryonic stem cell research had already been promulgated
and was waiting for effectuation. Therefore, the main research
institution, the College of Veterinary Medicine, Seoul National
University, to which Dr. Hwang and his research lab belonged,
should have formed its own IRB or should have made a review
agreement with an outside IRB on this issue. However, nobody in the
college asked for it. Dr. Hwang was a superstar in the College of
Veterinary Medicine. It would have been practically impossible for
other professors to raise ethical issues about his work or his
methods. What the IRB of the College of Veterinary Medicine did, or
rather, did not do regarding the 2005 paper,[144] well illustrates this point.

Another body that could have reviewed the ethics of
Dr. Hwang's stem cell research was the Stem Cell Research Center
Ethics Committee. Despite Dr. Hwang's claim that his lab spent only
private money, there was a growing suspicion that they used public
grants.[145] The Stem Cell Research Center Ethics Committee
should have investigated the source of research funding, and if Dr.
Hwang and his research team spent grants awarded by the Stem Cell
Research Center, it should have exercised its review and oversight
authority over his stem cell research.

Why had it not done so? One possible reason might
be the close connection between the Stem Cell Research Center and
the researchers. Dr. Moon Shin Yong[146] had been the director of the Stem Cell
Research Center since its establishment,[147] and both Dr. Hwang and Dr. Moon were members of
the Stem Cell Research Center Ethics Committee. Another reason
could be the general lack of oversight power of the Stem Cell
Research Center Ethics Committee over the Stem Cell Research Center
and the researchers. The discrepancy between the Center and its
Ethics Committee has been a chronic problem. The Center has awarded
grants to research projects that had not been properly reviewed by
its Ethics Committee or that had not followed the order of the
Ethics Committee to further complement the research plan. According
to an investigation by the Democratic Labor Party of South
Korea[148] Policy Committee, the Stem Cell Research Center
granted approximately $33 million aggregate to 232 research
projects from 2002 to August 2005. Its Ethics Committee issued
conditional approval or complement-needed approval to 163 projects,
but the grants have been executed regardless of the follow-up
complements or fulfillments of the imposed conditions. For example,
in 2005, among 32 projects that had been ordered to correct ethical
defects, only 23 projects actually rectified the problems.[149]

Another presumable review body on ethics of stem
cell research was the KMA. If it had wanted, it could have
exercised its sanction power over doctors who participate in
research. However, this was also another practical improbability,
because the KMA restrain itself from sanctioning its members too
often, as the American Medical Association have done to its member
doctors. For such a controversial, philosophical and unclear issue
as stem cell research, it would have been quite difficult for the
KMA investigatory committee to reach a consensus to sanction a
doctor.

This regulatory and attitudinal loophole shows the
necessity of universal governmental regulation of stem cell
research regardless of the source of funding. After the
effectuation of the Bioethics and Safety Act of 2005, the
researchers have tried at least to meet this formality.

4) Too Close a Relationship between Dr. Hwang and
the Government Officials

Dr. Hwang maintained good relationships with
government officials. His friends or supporters in the government
were sometimes criticized for exercising their power too favorably
toward Dr. Hwang.

The most conspicuous was Prof. Park Kiyoung. She
was a confidant of President Rho Mu Hyun and had been the former
Chief Manager of the Presidential Advisory Council on Science and
Technology. During 2003 she actively participated in drafting The
Bioethics and Safety Act and had had considerable influence on
formulating the government's science policy. In early 2004 she was
appointed the Advisor to the President for Information, Science and
Technology and could now exercise even greater power.[150] Dr. Park had maintained a close relationship
with Dr. Hwang. While participating in the drafting of the
Bioethics and Safety Act, she also conducted two subprojects for
Dr. Hwang and for which she was paid approximately
$250,000.[151] Many people suspected that she had changed the
minor details of the Act[152] to make it more favorable to Dr. Hwang. She was
included as the 13th of the 15 coauthors of the 2004
paper for no known reason;[153] if anything, her citation as coauthor further
fueled the suspicion that she had exercised her power to remove
regulatory hurdles hindering Dr. Hwang and had received the
coauthorship as a payoff.

Dr. Lee Pilryeol, a science historian,
environmental activist and professor at Korea National Open
University, first questioned her contribution to the
article.[154] His criticism was that with her academic
background in plant molecular physiology, she could not have
contributed scientifically to the human embryonic stem cell
research conducted for the 2004 paper. However, Dr. Lee's article
did not arrest the attention of the major media until Cyranoski of
Nature magazine cited his article, again raising the specter
of suspicion.[155] When the Pressian , a progressive
Internet newspaper, translated most of Cyranoski's article into
Korean and expressed concern that the ethical issues raised by
Nature magazine could have a huge impact on the scientific
community,[156] Park offered her excuse through Pressian
's online bulletin board that she deserved the authorship because
of her participation in reviewing the ethical and scientific
sociological aspects of the paper.[157] Though her excuse was insufficient, the major
media, the public, and the government ignored the problem thus
raised as well as other ethical issues, and did not take any
measures in spite of the growing criticism from
bioethicists.[158] Dr. Park continued to support Dr. Hwang, and
helped him receive an unprecedented number of government
grants.[159] Her efforts to protect and save Dr. Hwang
continued until the fabrication became undeniable, at which point,
she had no other but to resign.[160]

The Minister of Information and Communication Jin
Daeje, and the Secretary for President for Policy Coordination Kim
Byoungjun, were two other important supporters of Dr. Hwang. As Jin
Daeje, Kim Byoungjun, Park Kyoung, and Dr. Hwang had such a
noticeably close relationship, people had nicknamed them the
"Hwanggeumbakjwi (meaning "golden bats" in Korean pronunciation)",
a title coming from the combination of their four surnames with
slight twist to the pronunciation. Each had known Dr. Hwang since
2001, and had vigorously supported his efforts. They even
circumvented governmental policies and guidelines to support him.
For example, the Ministry of Information and Communication awarded
Dr. Hwang a $4.3 million grant from the Advanced Backbone IT
Technology Development fund (grant IMT2000-C1-1).[161] Dr. Hwang's research had nothing to do with IT
technology, and grants for biotechnology were supposed to be
executed by other presiding ministries, such as the Ministry of
Health and Welfare or the Ministry of Science and Technology. But
then Minister Jin awarded this grant to Dr. Hwang to be used for
his stem cell research.[162] However, they were not criticized but praised by
the majority of the public for their support to Dr. Hwang.
Considering that government officials themselves felt free to
circumvent the rules to support Dr. Hwang, it would not likely for
them to scrutinize his research.

Dr. Hwang and his research team had declared on
February 18, 2004, right after the announcement of their 2004
paper, that they would not continue the stem cell research until
the Bioethics and Safety Act took effect the following year because
of ethical reasons. However, in direct contradiction to their
public statement, they resumed stem cell research in October
2004,[164] largely backed by the enthusiastic support of
the public and the major media. Such support enabled Dr. Hwang to
overlook many regulations. His team continued to research, and on
May 19, 2005, again announced that they had succeeded in creating
11 patient-specific, immune-matched human embryonic stem cells by
SCNT of skin cells using 185 unfertilized human eggs. [165] If true, this would have meant the creation of
“custom-tailored” stem cells for each patient with
remarkably improved efficiency. Producing stem cells for one
patient using about seventeen eggs exceeded any expectation and
even raised the possibility of commercialization. If the 2004 paper
had stunned scientists worldwide, this paper shocked them. Now Dr.
Hwang was worshiped by the South Korean people as a national hero.
From that time forward, Dr. Hwang acquired a superstar-like
authority and popularity that was almost invincible to any
criticism. The emerging voices of opponents were still too few and
little heeded.[166]

However, the 2005 paper had as many ethical
problems as those of the 2004 paper. Though this time the
researchers in his lab had paid more attention to regulatory and
ethical issues because the newly effectuated Bioethics and Safety
Act now criminalized many more forms of misconduct, the new
regulatory system still did not work properly. Many problems that
already existed in the 2004 paper continued or worsened, while new
problems surfaced under the reformed regulatory system.

1) How His Team Bypassed the Regulations

Resuming their research in September 2004, Dr.
Hwang's team announced that they would perform SCNT and deriving
NT-hESCs under the auspices and oversight of the Hanyang University
IRB for Human Subjects Research and Ethics Committee. However, this
IRB reviewed only factors concerning egg-donation; the ethics of
stem cell research remained untouched by this IRB.[167]

The Bioethics and Safety Act that took effect on
January 1, 2005 prohibited any human embryonic stem cell research
without the review of the institutional review board (IRB)[168] and the National Bioethics Committee
(NBC).[169] It also required final prior approval by the
Ministry of Health and Welfare.[170] However, its Addenda (3) allowed an exception,
which stated, "if a person who is carrying out research on somatic
cell cloning embryos for research purposes...at the time of the
entry into force of this Act meets the requirements of the
following subparagraphs, he/she may continue to conduct such
research with approval therefor from the Minister of Health and
Welfare: 1. He/She has been conducting research on somatic cell
cloning embryos for not less than three years; and 2. His/Her
research on somatic cell cloning embryos has been published in
related scientific journal at least once."[171] Dr. Hwang’s team was the only research
team in South Korea that could meet the requirement of Addenda (3)
when the Act took effect.[172]

His team received approval from the Minister of
Health and Welfare on January 12, 2005[173] in accordance with Addenda (3). In fact, it was
the first approval issued under the new Act. Dr. Hwang's research
was exempted from review by the NBC, which had not yet been formed.
The quickly formed IRB of the College of Veterinary Medicine at
Seoul National University (hereinafter the “IRB of the
College of Veterinary Medicine”), conducted a formalistic
review of the ethics of Dr. Hwang's stem cell research and approved
it on January 23, 2005.[174] As shown infra 4), the IRB of the College of
Veterinary Medicine was rife with ethical problems; some IRB
members listed on its documents did not even know that they had
been appointed members. Once Dr. Hwang's team was approved, they
faced no additional review or supervision.

2) Continuing Problems

Many problems presented supra II. 2. b. were
repeated and sometimes worsened in the research for the 2005 paper.
Review of egg procurements for the 2005 paper by the IRB of Hanyang
University Hospital remained to be insufficient.[175] The IRB did not properly review the incomplete
informed consent forms that were used for the egg donors. This time
the informed consent forms were disclosed through the supporting
online materials for the 2005 paper,[176] but they were severely criticized for lacking
critical information fully disclosing side effects that could arise
such as infertility or death.[177] Researchers did not comply with the requirement
to submit continuing monthly reports on egg donations and serious
side effects, if experienced by the donors. Rather, the IRB issued
approval regardless of the investigators' lack of
compliance.[178] Though the Hanna Women's Clinic received egg
donations from its own infertility patients, and provided
compensation to 25 of them by discounting or exempting the in vitro
fertilization fee (approx. $1,800 to $2,300 per person), such
actions went unnoticed by the IRB.[179] The IRB review of the 2005 paper became more
formulaic, as Dr. Hwang's popularity and fame had increased
substantially. Not one board member was willing to question him or
his methods.

Dr. Hwang received more government grants and
private donations, but his negligent or intentional spending
continued.[180] Most of the private donations that had begun to
amass exponentially from 2004 forward were not properly managed or
audited.

Again coauthorships were awarded arbitrarily. Oh,
Sun Kyung and Kim, Hee Sun, the 21st and 22nd
coauthor were cited as coauthors in the 2005 paper,[181] but their contributions had not been for the
2005 paper but for the 2004 paper.[182] Dr. D. H. Chung (Seoul National University
Hospital) was acknowledged for teratoma histopathology in the 2005
paper due to a similar reason.[183] The authorship of the other corresponding
coauthor, Dr. Schatten of the University of Pittsburgh, was also
problematic. Though many criticized that his contribution was not
sufficient to be awarded a corresponding coauthorship,[184] Dr. Schatten did not hesitate to emphasize his
role in analyzing data and writing the drafts for the 2005 paper.
But when the scandal broke, he retracted his previous statements
and admitted instead that his role had been very limited only to
insignificant matters. The University of Pittsburgh accepted his
excuses and concluded that his behavior did not fall into the very
narrowly defined category of "misconduct,"[185] but a number of ethicists believed he should
have been held to account.[186]

Dr. Hwang's ties with Korean government officials
not only continued but strengthened. The government even awarded
Dr. Hwang the title of "Supreme Scientist" and $3 million in
grants.[187] After the announcement of the 2005 paper, the
government offered him 25 billion won (approximately $25 million)
to construct a cutting-edge biotech research center to be named the
“Hwang Woo Suk Research Center,’’ the future home
for the “World Stem Cell Hub.”[188] Many government officials stood by him until the
very end.

3) The Structural and Functional Problems of the
NBC

The NBC was a new body, and the government had not
completely prepared for the new regulatory regime during the
one-year waiting period from the promulgation to the effectuation
of the Bioethics and Safety Act. When the Ministry of Health and
Welfare approved Dr. Hwang’s research on January 12, 2005,
its spokesperson commented that this approval was only temporary,
and Dr. Hwang would have to again seek approval under the new NBC
review guidelines as soon as the NBC was formed and the
Presidential Decree on Human Embryonic Stem Cell Research by SCNT
was issued.[189] He said that he expected that this would be
completed within a month.[190] Instead, it took an additional four months for
the government to form the NBC, and the NBC held its first session
on July 15, 2005. No Presidential Decree on Human Embryonic Stem
Cell Research by SCNT had been issued before the stem cell scandal
broke. Dr. Hwang’s 2005 paper as well as other projects on
SCNT stem cell research had thus been conducted solely under the
discretion of the Ministry of Health and Welfare based on the
requirements set forth in Addenda (3).

What could have been the reason for this delay? It
is likely that the government focused only on Dr. Hwang’s
research, for he had achieved such an unprecedented fame and
popularity as a scientist and thus had true political clout.
Mesmerized by the overly enthusiastic reports circulated by the
major media,[191] most of the Korean public shared the belief that
biotechnology, especially stem cell research, would be the magic
bullet that could cure any patient and ensure national prosperity.
These public sentiments strengthened the government’s blind
support of Dr. Hwang's research. Considering the mass hostility
against the MBC PD Notebook that had first attacked Dr. Hwang, it
would have been difficult for the government to go against such
strong public sentiment. Government officials therefore felt that
they had no reason to establish any restrictions against Dr.
Hwang’s research. However, other prominent research teams
such as that at the College of Medicine, Pochon Cha University or
Dr. Park Sepil’s team at Maria Infertility Hospital[192] that could not literally meet the requirements
of Addenda (3) but had the scientific background and expertise to
conduct SCNT stem cell research were statutorily blocked both from
gaining Addenda (3) approval and from obtaining NBC
approval.[193]

Then, why did the NBC fail to move quick enough to
review Dr. Hwang’s research? Wasn’t it the NBC’s
role to stop unethical and unreviewed research and to rein in the
government’s blind support and funding? However, the NBC
could not yet function properly due to structural problems, which
Prof. Lee Inyoung[194] pointed out at the Emergency Forum: to
Guarantee the Ethics and Integrity of Biotechnological Research
held in Seoul by the Korean Bioethics Association on January 24,
2006. The idea put forth by the forum may be summarized as the
structural politicization of the committee's members and the
limitation of their powers.

First, according to the Bioethics and Safety
Act,[195] among 16 to 21 members of the NBC (actually 21
members had been commissioned), one third, i.e., seven Ministers of
related departments would be automatically included, seven members
would be commissioned from scientists or the industrial sector, and
the remaining seven members would be commissioned from
“religious, philosophical, ethical, social science or legal
circles, non-governmental organizations ... or women” by the
President. As all the Ministers were to be appointed by the
President, they would be under the direct power of the President,
and the scientists would also generally be proponents of less
oversight and more support. However, members from other areas would
not necessarily advocate the need for strict review, because they
came from a variety of various fields and subscribed to a variety
of philosophies, especially since the President would commission
people sharing similar philosophical and political backgrounds with
him.[196] This means that any important decision made by
the NBC would tend to be under the full control of the President
and the government, and if the government’s position were
more favorable to research and development, there would be no
meaningful deterrence or review power that could be exercised by
the ethicists.[197] What exacerbated the inertia of the NBC was that
the committee sessions were to be called either only by the
chairperson who was also to be appointed by the President or by at
least seven votes of the members.[198] Considering the dynamics among the members,
gathering seven votes would not be easy. The fact that the NBC held
only two sessions during the first seven months (one in April and
one in October) underscores their structural inertia.

Another problem raised by Prof. Lee Inyoung at the
above forum[199] was the NBC’s lack of investigatory power.
Unlike other statutory committees in Korea, the NBC lacked the
power to conduct independent investigations, more specifically, to
subpoena witnesses, to call for testimony by related government
officials or experts, or to ask for the cooperation of other
administrative agencies. Its power was limited to investigation
through documents, which was too indirect and too insufficient to
enable it to achieve a meaningful outcome. This stemmed largely
from origin of the Bioethics and Safety Act. Due to the fact that
it was the result of political compromise, the Act had not made it
clear whether the NBC should be an advisory committee focusing on
setting policy (which was preferred by the scientists and biotech
companies), or a supervisory committee that could exercise
oversight and sanction powers over researchers (which was preferred
by ethicists, religious groups, and civil rights
activists).[200] The Act intended the latter, but given the lack
of supporting authority, the NBC could only function as a weakened
advisory committee.

In sum, under the Bioethics and Safety Act, if
several members of the NBC had raised questions regarding Dr.
Hwang’s research, they would not have gathered enough votes
to hold a session, and even if they could have gotten the necessary
seven votes and acquired the necessary consensus to initiate a
further investigation, their limited investigatory powers would
have prevented them from uncovering Dr. Hwang’s
misconduct.

4) The Problems of the IRB of the College of
Veterinary Medicine

Conflicts of interest have been always a chronic
problem of the IRBs. Can the doctors or professors who are working
in the same building with the investigators make neutral and
independent decision? Can outside IRB members who are paid by the
research institution or eventually by the investigators who provide
a large share of budget to the research institution be free from
such financial incentives? Would it not be too tempting to pressure
the IRB members to overlook some ethical considerations and receive
approval as soon as possible, especially when patent rights or
other financial interests are at stake? Many safeguards to avoid
such conflicts of interest have not worked well, even in the
countries with a long history of IRBs.[201] Another chronic problem of the IRBs is the lack
of education of its members. Reviewing research from an ethical
perspective is very different from conducting a scientific review,
but in many cases, the professors or researchers in the same
institute dominate the IRB, and they are not necessarily experts on
ethics. The IRB of the College of Veterinary Medicine failed in
both aspects.

One reason for its disastrous dysfunction or
nonfunction was that no IRB had existed at the College of
Veterinary Medicine prior to Dr. Hwang’s research. As
explained supra II.1.a, most IRBs in Korea were established
for the clinical trials of the new drugs. Therefore, their
expertise was on protection of human subjects in clinical trials.
At the College of Veterinary Medicine where no human experiments
had been conducted, an IRB should have been established from
nothing. As Dr. Hwang was a superstar in the College, he could
choose anyone he liked as an IRB member. The members he chose
mostly did not know what the IRB should review, and assumed the IRB
was simply a formality. All the problems are well illustrated in
the NBC report.[202]

Dr. Hwang and another coresearcher Dr. Lee Byung
Chun hurried to form the IRB of the College of Veterinary Medicine
in order to be approved under Addenda (3) of the Act.[203] They selected the IRB members and remarkably did
not even notify some of them that they had been appointed to the
IRB board. Members were mostly colleagues at the College of
Veterinary Medicine, and one outside member was a reverend who had
a seriously ill daughter and even later donated her somatic cells
to the “World Stem Cell Hub” established by Dr. Hwang,
hoping Dr. Hwang's research could cure her some day. The
IRB’s final approval that was included in the supporting
online materials of the 2005 paper was not signed by the
chairperson Prof. Lee Youngsun but by someone else, probably
someone on Dr. Hwang's team. Prof. Lee Youngsun later admitted that
he did not even know he was a member, let alone the chairperson of
the IRB until October 2005. Other officially listed members also
admitted their total lack of knowledge of their membership. By
October 2005, the IRB had held three meetings, but had kept no
proper records, so when it was ordered to submit its records to the
NBC, its members had to reconstruct them . The members were unaware
of the basic principles, for instance, that the investigators
should not participate in discussions or decisions; that the
members should not delegate their review power to others; that it
was the IRB’s duty to require continuing intermediary reports
from the investigators; and that the IRB should keep the research
protocol with other IRB documents, which the investigators were
handed back immediately after the review. Its SOP was identical to
that of the Seoul National University College of Medicine, which
was solely for the clinical trials of new drugs and lacked any
guidance for stem cell research. Above all, no review of the ethics
of human embryonic stem cell research by SCNT, one of the main
purposes of this IRB, had been conducted.

Another problem highly criticized by the NBC report
was the protective attitude the IRB displayed when the issue of egg
donation began to rise in November 2005.[204] The IRB of the College of Veterinary Medicine
conducted a very formalistic investigation and concluded that there
had not been any major ethical violations in Dr. Hwang's research
and attributed most controversies to the cultural differences
between the Eastern tradition and Western ethics codes.[205] This investigation report was released to the
press not by the chairperson of the IRB but by an official of the
Ministry of Health and Welfare under the President's Advisor, Park
Kiyoung’s order, to make the report appear to be more
credible.[206]

3. Revelation and
Aftermath

It is worth noting how Dr. Hwang's fabrication was
revealed and what happened afterwards.

For a while, Dr. Hwang enjoyed worldwide fame.
Governmental funding and private donations flowed to him.
Scientists all over the world wanted to make joint-research
agreements with him.[207] When Hwang declared that he had succeeded in
cloning an Afghan hound male puppy named
“Snuppy”[208] and released photos of him and the puppy taken
by a professional photographer on August 4, 2005,[209] his reputation reached an unprecedented level in
Korean science history. Meanwhile, ethical objections were being
stronger, especially from the Catholic Church of Korea, which
announced its plan to raise a 10 billion won (approximately $10
million) fund for adult stem cell research.[210] Still, until late 2005, most people would have
never questioned the ethics and integrity of Dr. Hwang’s
papers–they were too overwhelmed by his continuing successes
and continued to blindly worship him.

The revelation began by a whistle-blower. Ryu,
Young June, coauthor of the 2004 paper, had left the research team
in April 2004, disappointed by Dr. Hwang's exaggerated and hasty
press releases and other instances of ethical misconduct. When Ryu
heard the news of the 2005 paper, he immediately suspected
fabrication, because according to his expertise and knowledge, such
a quick achievement was technically impossible. He posted the
message on the confidential bulletin board of MBC (Munhwa
Broadcasting Corporation) that Hwang’s team paid the ova
donors for the human eggs, and there was also a possibility that
Hwang’s 2005 paper might have been fabricated.[211] Han Haksu, a producer of MBC's newsmagazine
“PD Notebook,” received this information on June 1,
2005 and began to investigate.[212] Han's team tried to keep the investigation
confidential, but rumors began to spread, and soon other newspapers
and government agencies began to pay attention to the issues
raised.[213] On November 9, 2005, the police start
investigation of the CEO of a company named "DNA Bank," who was
also an egg broker and provided ova for Dr. Hwang's team.
Acknowledging the suspicion surrounding ova donations, Gerald P.
Schatten of the University of Pittsburgh, the corresponding
coauthor of the 2005 paper, announced on November 11, 2005 that he
was suspending his ties with Dr. Hwang’ s team due to ethical
reasons.[214] On November 21, one of the coauthors of
the first paper, Dr. Rho Sung-il, confessed that he purchased eggs
from donors to conduct the research.[215] It was time for the PD Notebook to strike. On
November 22, 2005, the first accusation, “The Myth of Hwang Woo Suk and the
Suspicion over Eggs”
was broadcasted nationwide in South Korea.[216] The first among four in the series focused on
the issue of ova donations, especially donations by the female
researchers and ova trading. Han also claimed that when his
newsmagazine team had conducted DNA tests through a private DNA
testing facility comparing the original donors’ somatic cells
with the alleged patient-specific stem cell lines cloned from the
donors' cells, the result indicated that the stem cell lines were
different form the donors' DNA fingerprints.

The backlash was huge. Angry citizens blamed this
program for trying to scar a national hero with trivial charges for
ignorable ethical misdemeanors and impede the development of
biotechnology. Scientists scorned that Han and his team were trying
to conduct amateur scientific reviews beyond their ability. Women
volunteered to donate their eggs to support Dr. Hwang.[217] Major newspapers, usually the opposite side of
the MBC's political spectrum, criticized left-wing producers of the
program for having used unethical and coercive measures to
investigate with unpatriotic zeal. All of the twelve sponsors of
the program canceled their advertisement agreements with the MBC
under pressure from consumers. The Ministry of Health and Welfare,
based on the investigation of the IRB of the College of Veterinary
Medicine at Seoul National University, announced that there were no
major ethical violations.[218] Though the National Bioethics Committee’s
investigation was still in progress, when the MBC’s board of
directors decided to cancel the broadcasting of the second series
of PD Notebook, shut the program down, and sanction the producers
and journalists for resorting to coercive and unethical
investigative methods, it seemed that Dr. Hwang's reputation and
research would indeed be saved.

The story did not end here. Young South Korean
biotech scientists blogging on the Biological Research Information
Center (BRIC) Website began to post their analyses on the 2005
paper.[219] On December 5, 2005, an anonymous blogger posted
a message that several allegedly different photos included in Dr.
Hwang’s 2005 paper were actually derived and manipulated from
a single photo, and the similarity was discernable to
anyone.[220] The next day, another person logging in with the
username “areung” pointed out that the DNA fingerprint
data of the two different cells were so similar in Hwang’s
2005 paper, and that they were an impossibility in the real world.
These two messages were rapidly disseminated through the Internet
and finally led the science professors at Seoul National University
to ask for further investigation.[221] When scientific evidence of falsification
became evident, Dr. Hwang tried to defend himself based on the
authority of the journal Science .[222] His fate was doomed, however, when his
co-researcher, Dr. Rho Sung-il of MizMedi Hospital, confessed,
"nine of the 11 stem -cell lines Dr. Hwang claimed to have created
in the 2005 paper don’t even exist."[223]

Further revelations followed in the wake of Dr.
Rho’s confession. Immediately resurrected, PD Notebook
broadcasted the second series, “Why PD Notebook Asked for
Reinspection” on the same day. In the program, a junior
researcher, Kim Sunjong, confessed that he created 9 non-existing
stem-cell-line data from only 2 stem-cell lines upon Dr.
Hwang’s order.[224] Seoul National University quickly formed its own
investigative committee and declared on December 23, 2005 that the
data of 11 stem cell lines described in the 2005 paper were
fabricated from only 2 stem cells.[225] The committee announced[226] after further investigation that both the 2005
paper and the 2004 paper were fabricated while the research on
“Snuppy” was truthful.[227] This result was confirmed again by the
criminal investigation.[228]

According to the investigations conducted by the
Seoul National Investigation Committee[229] and the Seoul Central District Prosecutors'
Office,[230] the fabrications occurred as follows:[231]

In February 2003, one of the researchers in Dr.
Hwang's team created an embryo using Donor Rho's unfertilized egg
and cumulus cells and extracted stem cells from it. However, by
mistake, not Donor Rho but Donor Lee was recorded as the donor, and
Dr. Hwang believed that this embryo (codenamed NT-1) was created
from Donor Lee's cells. When the DNA extraction from the NT-1 stem
cell line was delayed (the DNA extraction was necessary for DNA
fingerprinting to prove that the stem cell line and the donor's
somatic cell had the same DNA), he ordered his subordinate
researchers to divide DNA materials extracted from the donor's
somatic cell (in this case, Donor Lee's somatic cell) into two
tubes and send them to a DNA inspection institute as if one were
extracted from the stem cell line and one were from the donor's
somatic cell.[233] No doubt the results of DNA fingerprinting of
both tubes were identical, and those data were presented in the
2004 paper. Photos of the NT-1 stem cell line or teratoma were
substituted with clearer photos of completely different cells, and
details of various test results were also changed. It is still
unclear whether the NT-1 embryo was created by the autologous
nuclear transfer using donor Rho's egg and somatic cells, or by the
parthenogenesis resulted from the imperfect nucleus removal from
the oocyte and inadvertent input of the polar body into it.

From September 2004, Dr. Hwang's team began
research on creating patient-specific stem cells. They created
embryos by SCNT and cultured them to blastocysts, though with a
lower success rate, since they had used far more eggs than
presented in the paper. The inner cell mass (ICM) of the first
successfully grown blastocyst (codenamed NT-2) was seeded in feeder
cells (they were mouse feeder cells, not human feeder cells as
presented in the 2005 paper) in late September 2004. As Dr. Hwang's
expertise was on culturing blastocysts, not on deriving stem cell
lines from blastocysts, he completely relied on Kim Sunjong, a
junior researcher in Hwang's team and also researcher at MizMedi
Hospital. On October 5, 2004, the ICM stopped growing and was
separated from the feeder cells, which signaled the experiment had
failed. Kim Sunjong, frustrated and desperate, went to MizMedi
Hospital and brought a stem cell line (codenamed Miz-4) he had been
culturing from a residual embryo made from in vitro fertilization.
He secretly mixed this cell line into the NT-2 ICM, and reported
that he succeeded in deriving a stem cell. When Dr. Hwang and other
coresearchers did not realize his misconduct and praised him
instead, Kim became braver and created additional five stem cell
lines (codenamed NT-3 to NT-7, that actually had come from MizMedi
Hospital) using the same method as he had in December 2004.

In early January 2005 those NT-2 to NT-7 stem cell
lines were contaminated by accident, and only NT-2 and NT-3 were
left. Though the research team tried to make additional stem cell
lines (NT-8 to NT-12; they were in fact created by Kim Sunjong with
the same mixing method), no embryo had grown enough to derive stem
cell lines in time for the deadline to submit the paper. Dr. Hwang,
eager to publish the paper as early as possible to ensure patent
rights and fame, ordered Kim Sunjong to duplicate the data and
photos of the NT-2 and NT-3 stem cell lines and fabricate data for
nine more non-existing stem cell lines. Other data were also
fabricated and nobody except Kim Sunjong had known that even NT-2
and NT-3 were not real patient-specific stem cells. In the 2005
paper, Hwang's team proudly claimed that they succeeded in deriving
11 stem cell lines with far more efficiency. When the Seoul
National University Inspection Committee conducted the DNA
fingerprinting test, it was revealed that NT-3, NT-3, and other
stem cell lines derived after the submission of the paper were not
patient-specific stem cell lines created by SCNT, but common stem
cell lines derived from the fertilized embryos preserved at MizMedi
Hospital. This result was reconfirmed by the investigation
conducted by the Prosecutors' Office.

The Prosecutors' Office, finalizing the
investigation, analyzed the causes of this scandal as resulting
from: 1) the researchers' lack of integrity and ethics; 2) the
rigid and authoritative research environment; 3) poor management of
research records; 4) lack of principles in distributing
coauthorships; 5) a formalistic review by the IRBs; and, 6) lack of
transparency of the research budget.[235]

The journal Science retracted both the 2004
and the 2005 papers as irrefutable scientific evidence exposed the
fraud.[236] Dr. Hwang was dismissed from the university and
his team's coresearchers were also sanctioned.[237] Criminal investigations were begun on fraud,
embezzlement and egg donation, and six people, including Dr. Hwang
have been indicted.[238] The NBC announced their intermediary report on
February 2, 2006, in which various ethical wrongdoings were
revealed.[239] The Bioethics and Safety Act itself is under
scrutiny and destined for total reform. South Korean citizens
showed mixed reactions to this scandal initially, but after
observing the criminal investigation, most people are now
determined to prevent the repetition of similar scandals and to
clean up the whole research process. The thorough and relentless
investigations conducted by a host of offices, agencies and
committees testifies to this determination.

. Conclusion:Lessons of the Stem Cell Scandal

In this scandal, researchers skipped many ethical
and regulatory issues to achieve the goal quickly. Financial and
research records were insufficient and ambiguous. Two related IRBs
did not properly function. The Bioethics and Safety Act of South
Korea allowed too many exceptions. The NBC, main governmental
oversight body, did not have the structure and resources to oversee
the stem cell research. Above all, too much enthusiasm nullified
all the regulatory safeguards.

Once we recognize the problems, we can also find
their answers. In the United States, scientific misconduct cases at
four major research centers in 1980 led to the establishment of the
Office of Research Integrity.[240] The Tuskegee syphilis study scandal in 1972 led
to the
enactment of the National Research Act in 1974[241] and the announcement of the Belmont
Report in 1978.[242] We may learn from them.

Three pillars of regulation should come together in
research ethics. One is the self-regulation by the researchers,
another is the IRB review that can closely follow the conducts of
researchers, and the third is the legislative and governmental
actions that can facilitate researchers' self-regulation and the
IRBs' thorough and timely review.

To encourage self-regulation, first, the education
of investigators on research ethics should be reinforced. Though
mandatory ethics education might be deemed a formality, the
starting point should be to know what is ethical and what is not.
Especially, in a field such as biotechnology which raises so many
novel issues, for instance, what life is, or how to weigh life,
philosophical training and introspection is needed. Second, given
the acknowledgement that "university science becomes entangled with
entrepreneurship; knowledge is pursued for its monetary value; and
expertise with a point of view can be purchased,”[243] honor and conscience-based academic
self-regulation should be reconsidered. Strict auditing of research
grants and full disclosure of financial interests should be the two
mandatory underpinnings of regulation. Third, more equitable and
transparent distribution of coauthorship is critical to self
regulation. Each researcher should be accountable and responsible
for what she does.[244]

It is the role of the IRB to review the ethics of
the research. The traditional IRB model is now facing a new
challenge. In biotechnological research, the ethics of the project
itself and the researchers' social responsibility do matter as well
as the protection of human subjects. Therefore, at least some of
the IRB members should have the requisite philosophy or ethics
background needed to review the fundamental ethics of the research.
Another obligation that should be performed by the IRB is
risk/benefit analysis. Novel factors should be considered when
conducting risk/benefit analyses of biotechnological research
projects. Is it okay to use 300 ova to create one stem cell line,
which cannot cure disease immediately but will increase the
possibility of future success? If it is not okay, how many ova
shall be used? If other mammals' ova are used instead, is it
riskier in that it might harm human dignity and transfer animal
viruses to human beings, or is it less risky in that it causes less
harm to ova donors? A risk/benefit analysis is in nature
case-specific. Regardless of the existence of laws legislated, the
primary analysis should be conducted by the local IRB. The IRB
should also put more emphasis on avoiding conflicts of interest.
Establishment of joint IRBs or regional IRBs, certification or
license of IRB members, and registration of local IRBs may improve
the independence of the IRBs. We should certainly study ways to
improve IRB performance.

The National Bioethics Committee (or any form of
advisory committee or oversight committee at the national level)
should set the basic ground rules governing how IRBs should
function. Though many major questions, such as whether we should
approve therapeutic cloning or ova trading, may be answered by the
legislature, many other questions smaller in scope but no less
important should be discussed and answered by the NBC. The NBC
should be more democratized to avoid politicization and to achieve
free and impartial discussion. The function of the NBC should be
separated into policy setting and oversight, and for the former,
the diversity of members and the independence of the IRB should be
increased; its sessions should be more open and accessible to the
public; and various interest groups should have an opportunity to
speak at the committee's sessions. For the oversight function, an
administrative body that has the authority to conduct regular
inspections of research institutions and their IRBs and to run
educational programs for IRB members (this function may be
outsourced) should be established. In establishing and running this
regulatory system, we should rely on the principles of respect for
persons, beneficence, and justice.[245]

[]* According to the Guidelines for
Romanization of Korean (July 7, 2000, Ministry of Culture and
Tourism of the Republic of Korea, Public Notice 2000-8), in
Romanizing Korean names, surname should go first, and given name,
generally composed of two syllables, should be spelled as a single
word (e.g., Han Aera). But putting a hyphen between the two
syllables of given name is permitted (e.g., Han Ae-ra), and in case
a person had already made and used a Romanized name prior to the
public notice of the Guidelines, she is permitted to use it
continuously despite the current Guidelines. Due to such
exceptions, the actual usages of Romanized Korean names are very
confusing. E.g., Dr. Hwang's name can be Romanized as 1) Hwang
Useog (in accordance with current Guidelines), 2) Hwang Woo Suk (in
accordance with the continuous use exception), or 3) Woo Suk Hwang
or Woo-suk Hwang (putting the surname last in papers published in
English). In this paper, I first follow the general principles of
Guidelines, but when the spellings are different from the
Guidelines in published documents, respect them as exceptions, and
to avoid confusion, sometimes put a comma between the surname and
the given name.

For an English-version news summary on the
committee’ s report,
see Kim Jong-won, Hwang’s Team in Ethical
Minefield over Ova: Panel , The Korea Times, Feb. 2, 2006.
Available online at
http://times.hankooki.com/lpage/nation/200602/kt2006020218595910510.htm
(last visited on March 2, 2006).

[5] For the general overview of research ethics,
see Adil E. Shamoo & David B. Resnick, RESPONSIBLE CONDUCT OF RESEARCH (Oxford University
Press 2003); and David H. Guston and Kenneth Keniston eds.,
THE FRAGILE CONTRACT (The MIT Press
1994). For the integrity and accountability problem, see
William Broad & Nicholas Wade, THE
BETRAYERS OF TRUTH (Simon & Schuster 1982); and Patricia
Woolf, Integrity and Accountability in Research 82-101
inTHE FRAGILE CONTRACT (Guston
& Keniston eds., supra ). For the conflicts of interest
problem, see Sheldon Krimsky, SCIENCE
IN THE PRIVATE INTEREST (Rowman & Littlefield
Publishers, Inc. 2003). For science and media, see Dorothy
Nelkin, SELLING SCIENCE: HOW THE PRESS COVERS
SCIENCE AND TECHNOLOGY . (2nd revised ed. Freeman 1994).

[6] Broad & Wade, supra footnote 5 at 61-62.
Actually the authors of this book are skeptical about this
three-step self-regulatory mechanism and well illustrates its
insufficiency in preventing scientific misconduct. This stem-cell
scandal would be another example.

[7] For the background to the trade disputes between the
two countries and its consequences, see Anna Y. Park,
International Trade: Agreement Between the United States and the
Republic of Korea Concerning Insurance Market Access and
Intellectual Property Protection in the Republic of Korea, July 21,
1986 , 28 Harvard Int'l L.J. 166 (1987).

[9] The situation of South Korea at that time was
similar with that of India before the Indian government accepted
the western patent system on December 26, 2005. Many executives of
South Korean pharmaceutical companies still lament that South Korea
conceded to the pressure of the United States too early, and should
have been allowed additional time to further develop the domestic
pharmaceutical industry.

[11] The first new drug that won the approval of the
Korea Food and Drug Administration was "Sunpla inj.® ," an anti-cancer agent developed by
SK Chemicals. It took nine years from the initiation of the
research (May 1990) to approval (July 14, 1999). For the
introduction of the drug, see the official website of the
company, http://www.skpharm.com/english/product/ProductSunpla.asp
(last visited on Mar 23, 2006). After twelve years of research and
clinical trials, FACTIVE® , a
quinolone antibiotic developed by LG Life Sciences, won the
approval of the Food and Drug Administration of the United States
in April 2003. For the introduction of the drug, seehttp://www.lgls.co.kr/eng/rd/wonder.jsp
(last visited on March 23, 2006).

[12] The Guidelines for Korean Good Clinical Practice,
Dec. 28, 1987. Ministry of Health and Welfare, Public Notice No.
1987-87.

[13] The Guidelines for Korean Good Clinical Practice
(Amendment Jul. 27, 1995). Ministry of Health and Welfare Public
Notice No. 1995-39. Most IRBs in Korea were established after this
1995 amendment. For the history and status of IRBs in Korea,
see Kim Ock-joo et al., Current Status of the
Institutional Review Boards in Korea: Constitution, Operation, and
Policy for Protection of Human Research Participants , J Korean
Med Sci 2003; 18: 3-10. Available online at http://jkms.kams.or.kr/2003/pdf/02003.pdf
(last visited on March 24, 2006).

[15] International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for
Human Use, Guidelines For Good Clinical Practice E6 (R1)
Version , Jun. 10, 1996. Available online at http://www.ich.org/LOB/media/MEDIA482.pdf
(last visited on March 23, 2006).

[16] The first Korean Supreme Court decision that
directly acknowledged the informed consent doctrine was Daebeobwon
pangyul (Supreme court decision) 86DaKa1136 [Damage] delivered on
April 28, 1987. In this case a treating surgeon did not offer full
explanation of the expected side effects of tissue transplantation
surgery when getting the consent from the patient. The Supreme
Court affirmed the lower court’ s decision that awarded full
compensatory damages to the patient.

[17] In Daebeobwon pangyul (Supreme court decision)
93Da52402 [Damage] delivered on Feb. 10, 1995, the court decided
that "in case the patient claims only compensatory damages for the
emotional distress from the loss of the right to choose and
self-determination caused by the lack of informed consent, she
needs to prove only the fact that the physician provided no or
insufficient information to her." This decision has thus far been
followed in similar cases.

[18] Korean Medical Association, The Guidelines of
Ethics for the Medical Profession , Nov. 15, 2001 (language:
Korean). The main catalyst for the issuance of the Guidelines was
the so-called "Boramae Hospital case." In 1997, a patient underwent
brain surgery at Boramae Hospital (a public hospital run by the
Seoul municipal government) and had been recovering, but his family
demanded the treating physician to stop further treatment and
discharge him, largely due to financial reasons. The physician
agreed and discharged the patient, in spite of his knowledge that
this discharge would certainly cause the patient's death. The
patient died immediately after he arrived home and the artificial
respiration was removed, and both the physician and the family
members were convicted of murder at the trial. The appeals court
affirmed the conviction with minor changes (the murder conviction
of the physician was changed to accessory to murder), and the
Korean Supreme Court also affirmed it (Daebeobwon 2004. 6. 24.
pangyul 2002do995). The trial court decision delivered in 1997
alarmed the medical society and precipitated the issuance of a
medical ethics code and the establishment of hospital ethics
committees.

[25] Though the title was changed to Biotechnology
Support Act (Jan. 5, 1995, Act No. 4938, partial amendment), and
there have been eight additional partial amendments, its basic
structure has not changed.

[26] Kim, Mikyoung, An Overview Of The Regulation And
Patentability Of Human Cloning And Embryonic Stem Cell Research In
The United States And Anti-Cloning Legislation In South
Korea, 21 Santa Clara Computer & High Tech. L.J.
645, 682-683.

[28] Yujeonja Jaejohap Silheom Jichim (The Guidelines on
Recombinant DNA Experiments) Art. 23, April 22, 1997, Ministry of
Health and Welfare Public Notice No. 1997-22. It stated that the
head of the related ministry, agency or research institute on
biotechnological study and industry should develop measures to
prevent ethical problems that might be caused by biotechnological
experiments, but no specific or binding regulation ensued. Other
clauses of the Guidelines are mostly on the prevention of
biohazards.

[31] Sheryl WuDunn, South Korean Scientists Say They
Cloned a Human Cell , New York Times Dec. 17, 1998 A12. It
ended as a farce, as the researchers gave up further study and left
no scientific record overwhelmed by the domestic and international
ethical concerns. For the reaction of the medical profession to
this incident, See Kim Jeongsu, Silon:
Saengmyeongbogje-Yeongu-E Daehan Daehan-Uisahyeobhoe-Ui Ibjang (The
Position of Korean Medical Association on Human Cloning
Research) , J. Kor. Med. Association 42-9 (1999) 826, 826-829
(Language: Korean). Available online at
http://www.kma.org/windowpopup/pdfpopup.asp?pdfurl=99095.pdf&title=½Ã·Ð
/»ý¸íº¹Á¦¿¬±¸¿¡
%20´ëÇÑ
%20´ëÇÑÀÇ»çÇùÈ¸ÀÇ
%20ÀÔÀå
&listownseq=26 (last visited on March 25, 2006).

[32] The Korea Times, "First Clone of Calf Born in
Korea," Feb. 19, 1999. Dr. Hwang Woo Suk at the College of
Veterinary Medicine, Seoul National University announced in Feb.
1999 that he succeeded in cloning a cow named Younglong.
Available online at
http://search.hankooki.com/times/times_view.php?term=hwang+cloning+cow++&path=hankooki1
&media=kt (last visited on March 26, 2006).

[33] Alarmed by the attempted human cloning by the
researchers of Kyunghee University (supra Footnote 29), the
Korean Medical Association formed an investigative subcommittee
(ironically the subcommittee included Dr. Hwang and he played a
major role in prohibiting the researchers of Kyunghee University
from conducting further cloning experiments) on December 23, 1998.
In January 1999 the subcommittee recommended not to conduct human
cloning until a national policy was set, and later issued the
"Guidelines on Research of Cloning Lives " (Korean Medical
Association, May 1999). The guidelines prohibited any research on
human embryos for the purpose of human cloning (Art. 4 ‚ 1.),
implantation of cloned embryos in human uterus (Art. 4 ‚ 4.),
any experiment with embryos exceeding 14 days after fertilization
or nuclear transfer (Art. 4 ‚ 2.), and trading of sperms,
eggs or somatic cells (Art. 8 ‚). It also suspended the
approval of experiment on embryos that did not exceed 14 days from
the fertilization or nuclear transfer until any authoritative
government policy was established (Art. 4 ‚ 2). For
background to the issuance of the Guidelines, see Kim
Jeongsu, supra footnote 31.

[36] They differed in "who or what should be granted the
authority: 1) to determine the scope of permissible research
employing SCNT; 2) to administer the research and development in
biotechnology; and 3) as to what legislative actions should be
taken regarding other bioethical issues." Kim, supra
footnote 26 at 683.

[37] For example, Korean Medical Association,
supraGuidelines on Research of Cloning Lives ; The
Korea Health Industry Development Institute (KHIDI), The
Guidelines on Human Stem Cell Research and Supervision , Sep.
2001; Ethics Committee on Stem Cell Research Center, Stem Cell
Research Center Ethics Committee Guidelines for Review of Research
Proposals , May 2003. For further explanation, see Park,
Un Jong, BIOETHICS RESEARCH ETHICS AND
REGULATION (Seoul National University Press 2005),
112-133.

[38] Clonaid™ is "a self-described human cloning
company. It is openly associated with the Raë lian Movement, which sees cloning as
part of the path to immortality" (from Wikipedia.com catchword
"Clonaid").

[39] Kim Sangjo, Three Koreans are Pregnant: They
will be born in Six Months according to Clonaid , Kukminilbo,
Jul. 23, 2002 (Language: Korean). However, this news as well as
Clonaid's other announcements on success of human cloning has been
never verified by scientific evidence, and the company's actual
existence itself is under suspicion. Raja Mishra, Little behind
Clonaid, Files Reveal , Boston Globe April. 23, 2003.

[40] For the general overview of the law, see
Pak, supra footnote 37 at 180-212; and Kim, Mikyoung,
supra footnote 26 at 682-685. For more detailed comparison
of each draft and legislative process, see Gwak Sunheon,
The Legislation of Bioethics and Safety Act and Policy
Issues , Technological Trends in Health Industry (2003-winter),
152-162 (Language: Korean).

[41] This was deemed as a major setback by bioethicists
who had opposed human cloning generally.

[49] One notable clause is its Addenda (3). It states
that, "if a person who is carrying out research on somatic cell
cloning embryos for research purposes referred to in subparagraph 2
of Article 17 at the time of the entry into force of this Act meets
the requirements of the following subparagraphs, he/she may
continue to conduct such research with approval therefor from the
Minister of Health and Welfare: 1. He/She has been conducting
research on somatic cell cloning embryos for not less than three
years; and 2. His/Her research on somatic cell cloning embryos has
been published in a related scientific journal at least once." As
we shall later see, Dr. Hwang got the approval to conduct stem cell
research directly from the Minister of Health and Welfare based on
this clause, not through the review of National Bioethics
Committee.

[55] Hwang admitted in an interview with a producer of
"PD Notebook," a news magazine of MBC (Munhwa Broadcasting
Corporation, one of the three major broadcasting corporations in
South Korea) that he did not keep careful records of his cow
cloning research. According to his own explanation, he thought his
research did not have major scientific importance because papers on
mammalian cloning had already been published by other researchers;
he was not sure the experiment would succeed; and he could not
acquire accurate DNA inspection records as there was no molecular
biologist who could conduct the DNA fingerprinting in his team at
that time. PD Notebook of MBC, "How the Hwang Woo Suk Myth had
been Made," broadcasted on Jan. 10, 2006 23:05-24:00 (GMT+9:00)
(Language: Korean).

[56] Due to the lack of scientific records, after the
outbreak of the scandal, many people began to suspect that this
research might have also been faked. But considering the fact that
Dr. Hwang succeeded in cloning a dog in 2005, this cow cloning
might have also been truthful. The problem here is not its
truthfulness but the government's reckless funding based on
research that had not been properly peer-reviewed. Academic
earmarking or pork-barreling has been criticized in the United
States, too. See James D. Savage, Funding Science in
America (Cambridge University Press 1999).

[57] The Board of Audit and Inspection of Korea,
supra footnote 3 at 1-15.

[58] Dr. Hwang's research lab and the National Livestock
Research Institute under Dr. Hwang’ s technical advice produced the
alleged cloned cow embryos, and the government readily provided
dairy farms with these embryos until September 2001. However, a
follow-up inspection by the National Livestock Research Institute
in October 2001 revealed that only 77 among 838 embryos had been
successfully implanted in the surrogate cows' uteri, from which
only 39 calves were born. Further DNA inspections revealed that
among those 39 calves only 6 calves were grown from the embryos
produced by SCNT, and all other calves were grown from embryos
produced by common in-vitro fertilization, because the veterinary
technicians implanted multiple embryos produced by different
methods in a single uterus to raise the success rate. This plan was
eventually abandoned after the inspection. PD Notebook of MBC,
"How Hwang Woo Suk Myth had been Made ,"supra
footnote 55.

[60] Kim Tae-gyu, Researchers Clone Calves Resistant
to Mad Cow Disease , The Korea Times Dec. 10, 2003. Available
online at http://times.hankooki.com/lpage/200312/kt2003121016415810160.htm
(last visited on March 27, 2006). He had been given $5.5 million in
funding for the gnotobiotic (sterilized) miniature pigs and $4.3
million for the cows that supposedly had resistance to mad cow
disease. But he submitted no paper on the two alleged successes of
research projects and they have been never verified. The Board of
Audit and Inspection of Korea, supra footnote 3 at 1-15.

[61] Though he did not directly assure that he was the
one who would cure such incurable diseases, many patients believed
so based on his lectures and assertions, and gave him unprecedented
support.

[66] Gina Kolada, supra footnote 63. According to
the New York Times Interview with Dr. Lanza of The Advanced Cell
Technology, the company advertised to pay $4,000 for the
unfertilized egg donation, but could get only 19 eggs with "just a
few donors."

[69] Kass said in his e-mail message to the New York
Times, "the age of human cloning has apparently arrived: today,
cloned blastocysts for research, tomorrow cloned blastocysts for
babymaking," and that "in my opinion, and that of the majority of
the Council, the only way to prevent this from happening here is
for Congress to enact a comprehensive ban or moratorium on all
human cloning." Kolada, supra footnote 63.

[70] Korean Bioethics Association, Declaration:
Research in medical science and biotechnology must be conducted in
accordance with bioethical principles , May 22, 2004 (available
online at http://www.koreabioethics.net/pub.htm
). Also see Koo Young-Mo, A research ethics-based
analysis of the Korean scientists' human embryonic stem cell
research , the Journal of the Korean Bioethics Association 5-1
(Jun. 2004) 1-12 (Language: Korean. Its summary is available in
English). Available online at http://www.Koreabioethics.net/5-1/5.pdf
(last visited on March 27, 2006); and Song Sang-yong et al.,
Stem Cell Research in Korea , Science 13 August 2004:
944-945.

[73] Korean Bioethics Association, supra footnote
70; Koo Young-Mo, supra footnote 70; Song Sang-yong et al.,
supra footnote 70; Cyranoski, supra footnote 71; and
also Lee Pilryeol, Professors Times , Feb. 23, 2004
(Language: Korean). Prof. Lee said in his column that it was
unbelievable that more than ten women voluntarily came to the lab,
got the hormone injection, got diagnosed, and later opened their
bodies (for egg extraction).

[74] Cyranoski, supra footnote 71. When he first
interviewed one female researcher, she said that she and another
female researcher had donated their eggs. When the ethical problems
related to the donation by vulnerable subjects arose after the
interview, she denied her previous statement, and Dr. Hwang
explained that there had been no egg-donation by the researchers
and her previous answer was due to a misunderstanding of English.
Cyranoski, later at an interview with MBC's PD Notebook, stated
that when he asked a female researcher how they could get so many
eggs to be used for the research, she answered, "I don't know of
other cases, but I can say why I donated my eggs," and at his
repeated questions, she reconfirmed that she had donated her eggs.
PD Notebook of MBC, The Myth of Hwang Woo Suk and Suspicions
over Eggs , broadcast Nov. 22, 2005.

[75] The United Kingdom also prohibits egg-trading for
human embryonic stem cell research. See Select Committee on
Stem Cell Research (under The United Kingdom Parliament), Stem
Cell Research Report, Feb. 13, 2002, Chapter 8.23, stating, "we
recommend that the separation of clinical and research roles be
standard practice for donation of eggs or embryos. The prohibition
in the United Kingdom of payment to donors for gametes has been an
important element in preventing undesirable commercialisation of
this aspect of assisted reproduction and should be strictly
maintained." Available online at
http://www.parliament.the-stationery-office.co.uk/pa/ld200102/ldselect/ldstem/83/8309.htm
(last visited on April 21, 2006).

[76] Korean Medical Association, supra footnote
33 Art. 8 § 2. As well as
the egg trading, the KMA suspended any experiment on human embryos
until an authoritative governmental policy on this issue is
established.

[78] The Stem Cell Research Center Ethics Committee
Guidelines for Review of Research Proposals 1.5) states, "[e]mbryos
to be donated for research should not be offered in consideration
of monetary or any other compensation." Pak, supra footnote
37 at 128.

[80] World Medical Association, DECLARATION OF
HELSINKI: Ethical Principles for Medical Research Involving Human
Subjects Art. 8 states, "special attention is also required for
those who cannot give or refuse consent for themselves, for those
who may be subject to giving consent under duress... ". Available online at http://www.wma.net/e/policy/b3.htm
(last visited on March 30, 2006).

[86] How many eggs were used for each paper is still
unclear, because Dr. Hwang's research team have kept no proper
records on the receipt, use, and destruction of eggs except for
several researchers' personal research notes. National Bioethics
Committee, supra footnote 1 at 11. It is at least certain
that the total number would far exceed the 350 eggs Hwang claimed
to have used for the 2004 and 2005 papers.

[87] MizMedi Hospital paid 71 donors approximately
$1,500 per donor from 2002 to 2004. Dr. Rho Sungil, the director of
MizMedi Hospital, refused to further cooperate for fear of being
criminally charged for illegal egg trading under the Bioethics and
Safety Act since January 2005, and Dr. Hwang's team instead relied
on the Hanna Women's Clinic, which received egg donations from its
own infertility patients, and provided compensation to 25 of them
by discounting or exempting them from the in vitro fertilization
fee (approx. $1,800 to $2,300 per person). Seoul Central District
Prosecutors' Office, supra footnote 4 at 118-120.

[88] National Bioethics Committee, supra footnote
1 at 17. The egg broker (CEO of the DNA BANK) was later convicted
for the illegal egg trading, and the director of Hanna Women's
Clinic was also indicted for the violation of the Bioethics and
Safety Act and is now awaiting trial. Central District Prosecutors'
Office, supra footnote 4 at 18-19.

[89] One researcher who had donated her eggs expressed
her exasperation in the following e-mail message: "¡¦ though it was I who started it, I'm
scared. General anesthesia, self cloning (it's
inconceivable--cloning using my own eggs--how tough I
am)... I shouldn't have done it
this way, not giving up [my position] (in the research team) until
the end, not fighting against the professor. I will work harder to
forgive myself... ." National
Bioethics Committee, supra footnote 1 at 34. Though the
Prosecutor's Office concluded that there was no direct coercion of
the female researchers by Dr. Hwang, there is no question that the
procedures were still highly unethical. Dr. Hwang even requested
signatures of the 15 women researchers in his team on the informed
consent form for ova donation and kept the form, which suggests
that he wanted his female researchers to donate eggs. Id .
at 22-24.

[91] Among 92 women who donated their eggs through
MizMedi Hospital 15 women suffered from Ovarian Hyperstimulation
Syndrome and among them two women were even hospitalized. But as
donations at Mizmedi have not received any sort of IRB review,
these side effects were not reported or ever inspected. And Dr.
Hwang let the 15 women researchers in his team sign the informed
consent form for ova donation from the beginning. National
Bioethics Committee, supra footnote 1 at 22-24.

[92] The informed consent forms that went through the
IRB of Hanyang University Hospital for the research of the 2004
paper failed to mention several serious side effects such as
infertility. The forms of three other hospitals where most of the
egg extractions had been conducted were even less specific, only
emphasizing that the ownership of the eggs belonged to the
hospital. They presented only some of the possible side effects, or
simply stated, "I have received all the information on the side
effects. I hereby give my consent." and let the donors sign.
National Bioethics Committee, supra footnote 1 at 21.
Actually it is not enough for the researchers to simply state the
side effects. Recent guidelines on stem cell research ask for the
presentation of information on the purpose of the research, how and
where the eggs will be used, and the sources of research funding
and financial benefits the researchers might receive.

[97] The Stem Cell Research Center (SCRC) was
established in 2002 in Seoul National University for the purpose of
organizing and operating nation-wide stem cell research project
supported by the Ministry of Science and Technology, and intends to
grant $138 million to various stem cell research projects. Another
corresponding author of the 2004 paper, Moon Shin Yong, had been
the director of the Center since its establishment. Seehttp://www.stem.or.kr/english/
(last visited on April 1, 2006). On February 26, 2006 Dr. Moon was
excluded from any further research grant by the Center due to this
scandal.

[137] National Bioethics Committee, supra
footnote 1 at 49. If the information on research funding had been
clarified at an early stage, proper guidelines on human embryonic
stem cell research could have been applied, and many ethical
problems may have been prevented, as we have already seen in supra
2).

[139] National Bioethics Committee, supra
footnote 1 at 47. The principal investigator Hwang Yunyoung has
been suspected having exercised her influence on the IRB members
(most of whom were her colleagues at Hanyang University Hospital)
and later putting her name as a coinventor on Dr. Hwang's stem cell
patent application pertaining to the 2004 paper. Dr. Hwang Jung
Hye, another investigator and coauthor of the 2004 and 2005 papers
(she was a professor of Hanyang University Medical School), also
participated in the IRB's decision-making and helped the protocol
get the approval of the IRB. Dr. Park Munil, the chair of the IRB
of Hanyang University Hospital, later stated in an interview with
the MBC news magazine "PD Notebook" that if he had known that those
eggs were not donated but purchased, he would have never approved
the protocol; all the board members simply believed Dr. Hwang Jung
Hye's assertion that there was no problem with the eggs. Gang
Yanggu, Hwang Woo Suk Gyosuga Kkog Haemyeonghae-Ya Hal 4 gaji
Uihog (The Four Suspicions Dr. Hwang Should Answer) , The
Pressian, Nov. 23, 2005 (Language: Korean). Available online at
http://www.pressian.com/scripts/section/article.asp?article_num=30051123084502&s_menu=%EC%82%AC%ED%9A%8C
(last visited on March 30, 2006).

[147] For the history of the Stem Cell Research Center,
seesupra footnote 97.

[148] A left-wing party in South Korea. One reason they
could have raised ethical problems regarding research funding was
that they were comparatively free from the nationalistic and
mercantile sentiment that overwhelmed the two major political
parties on scientific research and development.

[151] One was "The Social Influence of the Analysis
of Information on Mad Cow Disease" and the other was "The
Ethical Review of Bio-organs and the Research on its Industrial
Development." The Board of Audit and Inspection of Korea,
supra footnote 3 at 14.

[157] Park Kiyoung, "I explain the issue of research
participation," the Pressian's Online Bulletin Board, May 8,
2004. (Language: Korean) (The post no longer exists, but it has
been copied to many blogs, e.g., the Technologists' Forum (a
Korean Website of technologists). Available online at http://www.engforum.org/news/read.php?idxno=446
(last visited on March 29., 2006)) She explained in that posting
that even though she had not participated in the scientific
research, she had discussed and reviewed the ethical issues of the
research, and had the expertise to do that through her experience
in drafting the Bioethics and Safety Act, in collaborating with
science sociologists and NGOs, and in publishing papers on
bioethical issues. She asserted that as extra-scientific issues
were very important to this kind of research, her contribution on
bioethical and science sociological review of the paper deserved
the authorship.

[159] South Korea's grant-allocating system is highly
centralized. Many grants are assigned not by peer review but by
earmarking popular projects or by related agencies' exercise of
discretion. Though such a "selection and concentration" policy has
proved very successful in semiconductors and other applied
sciences, this stem cell scandal seriously questions the validity
of such a policy.

[160] She advocated for Dr. Hwang openly when the egg
donation issue arose, and when the IRB of the College of Veterinary
Medicine, Seoul National University issued its investigation
report, which was actually an 'indulgence' of Dr. Hwang and his
coresearchers' ethical wrongdoings; she ordered an official of the
Ministry of Health and Welfare announce it instead of the IRB
itself to render the indulgence more official. The head of the
Bioethics Team under the Ministry of Health and Welfare later
admitted it and apologized. Gang Yanggu, Bokjibu "Park Kiyoung
Bojwagwani Sikineun Daero Haetda" (Ministry of Health and Welfare
admits, "we did as Advisor Park Kiyoung ordered") , The
Pressian Feb. 21, 2006 (Language: Korean). Available online at
http://www.pressian.com/scripts/section/article.asp?article_num=30060221100351&s_menu
=»çÈ¸ (last
visited on May 15, 2006).

[172] As explained in supra II.1.b., the
National Bioethics Committee was formed as late as April 2005, and
it did not issue any review guidelines until the stem cell scandal
broke. Therefore, it was practically impossible for other research
teams to get the review and approval of the NBC on the SCNT
research. This addenda had been highly criticized by biotech
researchers as a de facto monopoly, narrowly tailored for Dr.
Hwang, but it passed the National Assembly with no change.

[174] This meant that the Minister of Health and
Welfare did not wait for even the IRB review of the research
institution itself. On the other hand, the IRB of Hanyang
University Hospital conducted the review of oocytes and somatic
cells donation also for the 2005 paper as well as for the 2004
paper, and it gave its approval on Oct. 19, 2004, under KGCP. Hwang
et al., supra footnote 163 at Note 8; and its supporting
Online Material 1-3, 18-24 (available online at
http://www.sciencemag.org/cgi/content/full/1112286).

[175] National Bioethics Committee, supra
footnote 1 at 45-54. Most donated eggs from 2003 to 2005 could not
be distinguished clearly for each research, and the problems
surrounding egg donations and the IBR review of which were repeated
and overlapped with the 2004 paper. See II 2. b. 1),
supra .

[179] Seoul Central District Prosecutors' Office,
supra footnote 4 at 118-120. This practice had two problems.
First, compensation of any sort exceeding opportunity costs is
punishable under the Bioethics and Safety Act. Second, recruiting
from its own patients creates tension in the doctor-patient
relationship, because patients would feel obliged to volunteer to
get better treatment.

[180] The Board of Audit and Inspection of Korea,
supra footnote 3 at 1-15.

[186] Prof. David Magnus, criticizing Dr. Schatten's
behavior, analogized, "[he] may not have been the one who walked in
and robbed the bank. But he was the getaway driver who did not ask
why his friends wanted him to drive away when they ran out of the
bank" at a blog posting of bioethics.net. David Magnus,
Professor Schatten Did Suggest the Photographer ,
blog.bioethics.net Feb. 12, 2006. Available online at
http://blog.bioethics.net/2006/02/professor-schatten-did-suggest_12.html
(last visited on April 17, 2006).

[189] The Bioethics and Safety Act, supra
footnote 42, Art. 22 (2). It stated, "the categories, objects and
scope of that research provided in paragraph (1) for which an act
of transplanting the nucleus of a somatic cell may be performed
shall be provided for by the Presidential Decree after being
deliberated on by the National Committee," therefore, without a
Presidential Decree no stem cell research by SCNT could be approved
except for research which came under the Addenda (3) exception.

[191] The Solidarity for Biotechnology Surveillance, an
association of 13 civil rights and women’ s rights activists groups held the
Forum: "Is the Current Human Embryonic Research Acceptable?"
on August 25, 2005 in Seoul, South Korea. The overly enthusiastic
attitudes of major media were one topic of the forum. The panelist
Kim Myeongjin, lecturer of Sungkonghoe University, criticized that
the Korean media mostly ignored the ethical problems and technical
barriers of human embryonic stem cell research; praised Dr. Hwang
as if he could cure patients in the near future, thus disabling any
rational discussion with opponents, and put ethicists on the
opposite side of Dr. Hwang, depicting them as obstacles impeding
his urgent scientific research and development. He also pointed out
that the accolades by the western scientists and media on Dr.
Hwang’ s success was partly
to stimulate their own conservative governments and politicians, so
Koreans should not accept such praise too naively. What he
discussed in the forum was later published in a Korean magazine
entitled Environment and Life 2005 Fall. However, such
criticisms were also ignored by most major media.

[192] His team won a U.S. patent for technology
facilitating the extraction of human embryonic stem cells from
frozen embryos in Oct. 2005. See Kim Cheong-won, Research
Team Gets US Patent for Stem Cell Technology , The Korea Times
10-17-2005. Available online at http://times.hankooki.com/lpage/200510/kt2005101717184810160.htm
(last visited on April 17, 2006).

[196] Actually Yang Samseung, the chairman of the
committee, was President Roh Mu Hyun’ s attorney and also shared the
supportive view of the President toward biotechnology and Dr.
Hwang. Yang later gave legal advice to Dr. Hwang when ethical
issues were raised, and had to resign due to the conflicts of
interest.

[197] This is exactly opposite from what happened in
the United States. President Bush dismissed Dr. Blackburn and Dr.
May from the President’ s
Council on Bioethics on February 27, 2004. Both had disapproved the
restrictive stem cell policy of the Bush administration. Their
seats were filled by persons more supportive of the President. To
show the ironic symmetry with the South Korean situation, let me
directly cite from the report. "[Dr. Blackburn] was one of only
three full-time biomedical scientists on the panel, which, even
prior to her dismissal, was weighted heavily to nonscientists with
strong ideological views. While no one disputes that nonscientists
should play an important role on a bioethics panel, it is equally
important that scientists, with strong biomedical expertise,
provide the necessary scientific context for the panel." The Union
of Concerned Scientists, Scientific Integrity In Policy Making:
Further Investigation of the Bush Administration’s Misuse of Science,
the July 2004 update. Available online at
http://www.ucsusa.org/scientific_integrity/interference/reports-scientific-integrity-in-policy-making.html
(last visited on April 14, 2006). In the case of the NBC, the
bioethicists were outnumbered and overwhelmed by scientists and
government officials.

[205] Ministry of Health and Welfare, The Result Of
The Investigation On The Ova Donation Of Hwang Woo-Suk Research
Team Of Seoul National University (Press Release) , Nov. 24,
2005 (Language: Korean). Available online at
http://www.mohw.go.kr/download.tdf?f=/2005/11/20051124182337799088_1.hwp&fn=????????11.24.hwp&table=gp_tb_data_file
(last visited March 10, 2006)

[206] Later Kim Heonju, the Chief of the Bioethics Team
under the Ministry of Health and Welfare, apologized through an
e-mail to the members of the NBC that it had been inappropriate for
the Ministry to announce the misleading investigation report of the
College of Veterinary Medicine IRB instead of the chairperson of
the IRB, and they had been ordered to do so by Park Kiyoung, the
advisor to the President. Gang Yanggu, Bokjibu, "Park Kiyoung
Bojoagwani Shikineun Daero Haetta" (the Ministry of Health and
Welfare did as ordered by the President's Advisor Park Kiyoung)
, The Pressian, Feb. 21, 2006 (Language: Korean). Available online
at
http://www.pressian.com/scripts/section/article.asp?article_num=30060221100351&s_menu
=»çÈ¸ (last
visited on April 17, 2006).

[207]E.g., Scottish embryologist Ian Wilmut,
who cloned the a sheep named Dolly in 1996, made a joint study
agreement with Dr. Hwang (it is quite ironic that Wilmut himself is
blamed for the dubious coauthorship on Dolly paper now), and Hwang
announced that he would cooperate in a joint diabetes study with
Harvard University team led by Dr. Douglas Melton. Kim Tae-gyu,
Support for Hwang Coverage , The Korea Times 05-23-2005,
available online at
http://times.hankooki.com/lpage/biz/200505/kt2005052319363411900.htm
(last visited on Feb. 10, 2006); Kim Tae-gyu, Hwang to Stage
Joint Cloning Research With Harvard Team , The Korea Times Jun.
3, 2005, available online at
http://times.hankooki.com/lpage/biz/200506/kt2005060320431911910.htm
(last visited on March 11, 2006).

[212] Han Haksu, Myth of Hwang Woo Suk in
ourselves , PD Journal of the Broadcasting Producer Association
of Korea, 2006-1-11 (Language: Korean). Available online at
http://www.pdnet.or.kr/newspaper/newsview.asp?cd=8799
(last visited Mar 9, 2006). He stated in this postscript to the
program that when he was first informed of the suspicion he
immediately realized the difficulty of the situation but still felt
the urgency to investigate. He wrote, "if the fabrication of the
paper were true, it would be revealed eventually, and I felt the
pressure that it should be done by no other than a Korean news
media. It would be an unthinkable humiliation if, say, the New York
Times reported it first. The investigation therefore became
urgent."

[217] James Brooke And Choe Sang-Hun, South Koreans
Rush to Defend Cloning Researcher Against Criticism , The New
York Times Nov. 29, 2005, A11.

[218] Ministry of Health and Welfare, The Result Of
The Investigation On The Ova Donation Of Hwang Woo-Suk Research
Team Of Seoul National University (Press Release) , Nov. 24,
2005. Available online at
http://www.mohw.go.kr/download.tdf?f=/2005/11/20051124182337799088_1.hwp&fn=????????11.24.hwp&table=gp_tb_data_file
(last visited March 10, 2006) (Language: Korean). As we have seen
infra, this announcement itself was problematic.

[241] A scandal of "government involvement in research
on African-American men with syphilis who were left untreated so
that the researchers could study the untreated course of the
disease." Ken Gatter, Fixing Cracks: A Discourse Norm To Repair
The Crumbling Regulatory Structure Supporting Clinical Research And
Protecting Human Subjects , 73 UMKC L. Rev. 581, 596.

[242] National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research, The Belmont
Report: Ethical Principles and Guidelines for the Protection of
Human Subjects of Reserach , April 18, 1979. Available online
at http://ohsr.od.nih.gov/guidelines/belmont.html
(last visited on April 27, 2006).